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PURPOSE To determine volume fill levels, estimated costs, and force expulsion requirements per bottle of topical ophthalmic steroids commonly used in the United States. SETTING Tertiary care academic referral center. DESIGN Prospective laboratory investigation. METHODS Eight commercially available medications were tested: loteprednol 0.5%, loteprednol gel 0.5%, loteprednol gel 0.38%, difluprednate 0.05%, generic fluorometholone 0.1%, branded fluorometholone 0.1%, generic prednisolone 1.0%, and branded prednisolone 1.0%. Ten bottles of each medication were tested. A double-blinded method was used to measure actual bottle-fill volume and number of drops dispensed per bottle. The total perioperative cost per drop was calculated for each medication using average cash price. Force requirements were measured using a customized force gauge apparatus. Formulations were compared using Kruskal-Wallis one-way ANOVAs. RESULTS All formulations were able to cover postoperative periods commensurate with commonly used dosing regimens for cataract surgery. All medications had greater than sticker volume. Loteprednol 0.5% suspension and branded fluorometholone had the highest and lowest number of drops among the medications tested, respectively. Loteprednol 0.38% gel was the most expensive medication, while generic prednisolone 1.0% was the least expensive. Gel and branded formulations of ophthalmic steroids required less expulsion force compared to other tested formulations. CONCLUSIONS Volume fill levels, patient-incurred costs and expulsion force requirements per bottle of topical steroid medications vary widely. Clinicians may wish to consider these findings when determining their perioperative prescribing regimens.

Purpose: To characterize the sequelae of microsporidia keratoconjunctivitis (MKC) and outline its management. Methods: Retrospective analysis of microbiologically proven MKC returned with persistent disease between January 2015 and December 2019 was done. Demographics, clinical features, management, and outcome were analyzed. Results: Sixteen patients (21 eyes) of 332 treated for MKC returned with the persisting disease. The mean age of 11 males (68.7%), and 5 females was 35.1 ± 12.2 years. Three-quarter of them did not have a known predisposing risk factor and one-quarter of them were referred for chronic conjunctivitis. Past medications included topical antivirals (n = 8) and topical corticosteroid (n = 6). Three predominant presentations were persistent (>3 weeks) superficial punctate keratitis (SPKs, n = 7), sub-epithelial infiltrates (SEIs, n = 13), and uveitis (n = 2). The lesions recurred in eight eyes (SPK and SEI 4 each) after a disease-free interval of 60.4 ± 40.6 days; there were 13 episodes of recurrence. Topical low potent corticosteroids (loteprednol/fluorometholone), and tacrolimus ointment 0.03% were used in 17 (80.9%) and 8 (38%) eyes, respectively, for a mean duration of 44.8 ± 31.6 and 226.8 ± 180.5 days, respectively. At follow-up, 172.3 ± 183.6 days, visual recovery was statistically significant in persistent eyes (BCVA 0.07 ± 0.07 logMAR; P < 0.00001) but, not in recurrent eyes (BCVA 0.16 ± 0.08 logMAR; P = 0.07). Five of 21 eyes were left with residual significant scar. Conclusion: The sequelae of microsporidial keratoconjunctivitis are not uncommon. Topical 0.03% tacrolimus ointment appeared to be an effective corticosteroid-sparing agent for the treatment of SEIs and prevention of recurrence.

To evaluate the efficacy and cost-effectiveness of preoperative loteprednol versus flurbiprofen, when combined with moxifloxacin in maintaining intraoperative mydriasis and reducing postoperative complications. 200 cataract patients were divided into 2 groups. Group 1 receiving preoperative Flurbiprofen(0.03%) with moxifloxacin(0.5%) and Group 2 receiving Loteprednol(0.5%) with moxifloxacin(0.5%), three times a day 24 hrs prior to cataract surgery,followed by postoperative loteprednol(0.5%) and moxifloxacin(0.5%) in both groups. Intraoperative mydriasis and post operative complications were analysed. Patients were followed up on day 1, 1 week, 3 weeks and 7 weeks. Parameters evaluated included inflammation, pain, corneal edema, anterior chamber reaction (including cells and flare), intraocular pressure, CME. Intraoperative mydriasis obtained in both the groups was comparable with no significant difference. Postoperative visual outcome was also comparable but postoperative inflammation was slightly more in Group 1 (p This hospital based study in western Rajasthan revealed Loteprednol to be equally potent as flurbiprofen in maintaining intraoperative mydriasis along with significant reduction of postoperative complications while maintaining cost effectiveness and compliance as a single eye drop was used before and after surgery, with no steroid related complications.

To review current literature on the use of topical steroids for treatment of both aqueous-deficient and evaporative subtypes of dry eye disease (DED). Recent studies have shown that topical steroids are effective for the treatment of patients with moderate or severe DED who have failed to respond to more conservative measures. These medications are useful for patients with both aqueous-deficient and evaporative subtypes of DED. Although topical steroids are often used for a short period of time, patients with chronic ocular surface inflammation can benefit from long-term treatment. For this, low-potency steroids, such as loteprednol or fluorometholone, would be reasonable due to their reduced risk for increasing intraocular pressure. Topical steroids have proven beneficial in conjunction with other anti-inflammatory medications such as topical calcineurin inhibitors. As inflammation plays an important role in pathogenesis of DED, topical steroids may be considered for patients with refractory disease.

Aim: To study the complications with pterygium excision and conjunctival limbal autograft with patient’s own blood used as adhesive for graft. Materials and Methods: A prospective, cross sectional, timebound study including 52 patients with primary pterygium. Pterygium autograft was pasted over recipient bed using patients own blood without using sutures or fibrin glue. A 0.5 mm oversize graft was held in place for 5 minutes using blood at the pterygium excised site as adhesive. Post operatively after 24 hours, the eye was assessed under slitlamp for graft adherence, symptoms or any other complications and were advised topical moxifloxacin, loteprednol and lubricating eye drops. Patients were followed up on 7th day, 1st month and 4th month. Results: Out of 52 patients there were 30 males and 22 females with highest incidence among 35 to 55 years age group (78.85%). Majority of patients had grade 2 (76.9%) pterygium and most of them were farmers by occupation while most common indications for surgery were visual problems (48.07%) and cosmetic (40.38%) reasons. Conjunctival autograft remained in place in 49 patients. In 3 patients there was mild graft dehiscence, 1 patient had pyogenic granuloma which needed resurgery. Conclusion: Graft related complications can be reduced by meticulous dissection, accurate orientation of graft and ensuring holding onto the graft placement area for at least 5 minutes for adherence. Keywords: Pterygium, Autograft, Complications.

Background To compare the effect of loteprednol suspension eye drops after corneal transplantation with the effect of prednisolone acetate eye drops. Methods A total of 234 patients (234 eyes) who underwent penetrating keratoplasty (PKP) and lamellar keratoplasty (LKP) were retrospectively included. Patients who received 1 % prednisolone acetate eye drops were defined as 1 % prednisolone acetate eye drop group (n = 96), and patients who received 0.5 % loteprednol suspension eye drops were defined as 0.5 % loteprednol suspension eye drop group (n = 138). Results 35 cases in 1 % prednisolone acetate eye drops group and 27 cases in 0.5 % loteprednol suspension eye drops group developed corticosteroid-induced ocular hypertension, and were defined as prednisolone acetate group and loteprednol group. No significant differences were observed in the average intraocular pressure (IOP) at 1 week, 1 month, 3 months or 12 months postoperatively. There were significant differences in the average IOP between the two groups at 6 months postoperatively (P = 0.001). There were no significant differences in the average best corrected visual acuity (BCVA) at 1, 3 and 12 months postoperatively between two groups. The average 6-month postoperative BCVA was significantly higher in the prednisolone acetate group than the loteprednol group (P P > 0.05). Conclusions 0.5 % loteprednol suspension eye drops may be considered for long-term use after corneal transplantation.

PURPOSE: The purpose of this study is to compare the efficacy of topical cyclosporine (Cs) 0.05% alone and topical Cs 0.05% with loteprednol 0.5% in patients with moderate dry eye. STUDY DESIGN: This was a comparative, prospective, interventional study. PATIENTS AND METHODS: A total of 140 patients diagnosed with moderate dry eyes were randomly divided into two groups. Group A patients received treatment with topical loteprednol 0.5% started as QID dosage for 2 weeks and tapered to BID dosage over the next 6 weeks, topical Cs 0.05% BID and artificial tears. Group B patients received treatment with topical Cs 0.05% BID and artificial tears. All patients were followed over a period of 6 months with ocular surface disease index (OSDI) questionnaire, tear film break up time (TBUT), corneal fluorescein, and lissamine green staining scores. RESULTS: There was a significant difference in the symptoms and signs of dry eye in the group receiving combination of loteprednol 0.5% and Cs 0.05% as compared to the group receiving Cs alone evident by greater reduction in OSDI score, corneal staining, and improvement in TBUT and Schirmer's test values over a follow-up of 6 months. CONCLUSION: Combination therapy with topical loteprednol and Cs is significantly better than topical Cs alone on alleviating symptoms and signs in moderate dry eye patients.

Purpose: To know the pattern of presentations and management outcome of steroid induced glaucoma in vernal keratoconjunctivitis (VKC). Methods: Children of VKC using steroid with two of the following criteria were enrolled: Intraocular pressure (IOP) >21 mm Hg, glaucomatous optic disc and visual field defects. Misused topical steroids were classified in 4 groups; A- Highly potent drugs (dexamethasone, betamethasone), B- Moderate (prednisolone), C- Weak (loteprednol, fluorometholone), D- Unknown drugs. Active/conservative interventions were done to control IOP. Corrected distance visual acuity (CDVA), IOP, anterior segment and fundus examinations were noted. One-way ANOVA test and post hoc Tukey HSD test were used to compare the groups. Results: Out of 1423 VKC patients, 240 were using topical steroid without prescriptions. 92 eyes of 47 patients had steroid induced glaucoma. Hence prevalence of this complication was 3.30% in this study population. Mean age was 14.1 ± 3.8 years. Mean IOP was 38 ± 12 mm of Hg and mean vertical cup disc ratio was 0.67 ± 0.25. IOP was controlled by withdrawal of steroids (9 eyes), with antiglaucoma medications (27), trabeculectomy (57) and glaucoma drainage device (1). Mean CDVA at presentation was better in group C (0.23 log MAR). Mean IOP was highest in group A (43.1 mm Hg) followed by group D (40.5 mm Hg). At presentation 17 were blind (CDVA

Background: Topical corticosteroids have been the cornerstone in the management of postoperative inflammation following cataract surgery. Due to potential side effects of the older topical steroids like prednisolone acetate and dexamethasone or betamethasone, newer potent steroids preparation like difluprednate, loteprednol or fluorometholone are now being used at lesser dose and frequency to control inflammation. There is scanty literature on the efficacy of these drugs in preventing inflammation and macular oedema in the Indian population. Purpose: The purpose of this study was to compare the efficacy of difluprednate 0.05% against prednisolone 1% eye drops for control of inflammation following phacoemulsification. The adverse effects of both drugs were also evaluated in this retrospective study. Methods: This retrospective cohort study included 181 patients operated for age-related cataracts by a single surgeon at a tertiary referral eye hospital between December 2018 and March 2019. Patients received either difluprednate 0.05% emulsion (n=90 eyes) or prednisolone acetate 1% (n=91 eyes) after phacoemulsification with the same brand intraocular lens (IOL) and same phaco machine. The topical medication was initiated one day postoperatively and continued for six weeks in tapering dosage. Pain score (Visual Analogue Scale, VAS), conjunctival hyperemia, anterior chamber (AC) cell grading, corneal oedema, central retinal thickness, subclinical cystoid macular oedema (SCME), intraocular pressures (IOP) and best-corrected visual acuity (BCVA) were examined after one week and six weeks of cataract extraction. Results: There was no statistically significant difference observed with regards to pain score (no pain in any patients after six weeks), conjunctival hyperemia (no hyperemia in any patients after six weeks), AC inflammation (no reaction in any patients), central retinal thickness (234.44 ± 35.75µ vs. 234.8 ± 34.99µ, p-value 0.946), SCME (16.67% vs. 13.19%, p-value 0.511), IOP (16.8 vs. 15.47 mmHg, p-value 0.101) and BCVA (BCVA 6/6 in 57.7% vs. 70.32%, p-value >0.05) between both groups. The mean change in IOP in both the groups at one week (0 ± 4.4 vs. 1.87 ± 3.54, p-value 0.0007) and six weeks (−0.01 ± 5.53 vs. 1.88 ± 4.01, p-value 0.004) was significant. Conclusion: Both the groups were equivalent with regards to their therapeutic efficacy in controlling postoperative inflammation and restoration of vision following phacoemulsification.

Purpose. A meta-analysis was conducted to evaluate the efficacy and safety of topical treatments (including steroids and antibiotics) for adults with blepharokeratoconjunctivitis (BKC). Methods. The following databases were searched for relevant randomised controlled trials (RCTs): China National Knowledge Infrastructure (CNKI), Web of Science, MEDLINE, PubMed, Embase, and Cochrane Central Register of Controlled Trials database (CENTRAL). Two reviewers selected studies and analyzed the risk of bias independently. The treatments were loteprednol 0.5%/tobramycin 0.3% (LE/T) and dexamethasone 0.1%/tobramycin 0.3% (DM/T). The efficacy outcome measures were change from baseline (CFB) in composite scores of ocular symptoms and signs; the CFB in the signs composite scores for blepharitis, conjunctivitis, and keratitis at each visit; the total ocular adverse event incidence (AEs); and the incidence of intraocular pressure (IOP) increase after treatment. Prepost mean differences (MDs) were compared for continuous outcome variables, and incidences were analyzed for dichotomous data. The pooled effect sizes were analyzed using 95% confidence intervals (CIs) in a fixed-effect model. Heterogeneity was evaluated using the Q-test and I2 statistic. Results. The CFB to final visit in ocular symptoms and signs of BKC was not statistically different between the two treatments (95% CI, −0.33 to 1.50; MD = 0.58;P=0.21). The CFB in signs composite scores for blepharitis (95% CI, −0.16 to 0.48; MD = 0.16;P=0.32), conjunctivitis (95% CI, −0.55 to 1.76; MD = 0.61;P=0.30), and keratitis (95% CI, 0.00–0.28; MD = 0.14;P=0.05) was also similar with the two treatments. LE/T was a safer intervention than DM/T, with fewer overall adverse events (95% CI, 0.34–0.80; RR = 0.52;P=0.003) and significantly less elevation of intraocular pressure (IOP) (95% CI, 0.32–0.70; RR = 0.47;P=0.0002). Conclusions. DM/T and LE/T are both effective treatments for BKC, but LE/T may be a safer intervention.

Purpose To describe a reversible syndrome of epiphora, functional punctal stenosis, and chronic pretarsal conjunctivitis associated with corticosteroid or corticosteroid-antibiotic eyedrop use. Methods This is an Institutional Review Board-approved retrospective review of patients diagnosed with epiphora, punctal stenosis, and chronic conjunctivitis by a single surgeon (B.J.W.). These patients were subsequently invited to participate in a prospective study involving allergy skin patch testing for ophthalmic drops, common excipients, and active ingredients. Results Thirteen patients received a diagnosis of punctal congestion syndrome. The average age was 63 years (range, 41-93) and 69.2% were female. Findings were bilateral in 61.5%. All had used preserved drops in the affected eye(s). Various antecedent diagnoses resulted in treatment with preserved drops. Patients experienced epiphora for an average of 3.8 months (median, 3 months; mode, 3 months; range, 1-8 months) prior to presentation. Two patients had undergone punctoplasty which failed to resolve symptoms. 92.3% of patients had been taking tobramycin-dexamethasone drops, loteprednol drops, or a combination of both prior to presentation. All were taken off preserved drops. 69.2% were also treated with a preservative-free loteprednol etabonate 0.5% ophthalmic ointment taper. All improved. Partial relief of symptoms was achieved by an average of 1.6 months (median, 2 months; mode, 2 months; standard deviation, ±0.7 months) and resolution of symptoms by 2.5 months (median, 2 months; mode, 2 months; standard deviation, ±1.7 months). One patient underwent patch testing with strong positive reactions to formaldehyde and neomycin and a weak positive reaction to gentamicin. Conclusions Functional punctal stenosis is associated with topical ophthalmic preparations, especially preserved corticosteroids and antibiotic-corticosteroid combinations. Treatment consists of removal of all preserved eyedrops. Symptoms often improve over several months.

Purpose To report successful management of acute ocular graft-versus-host disease (oGVHD) by self-retained cryopreserved amniotic membrane (AM). Observations A 69-year-old male developed acute oGVHD following hematopoietic stem cell transplantation (HSCT) with severe dryness, pain, photophobia, and blurred vision, the right eye worse than the left eye. Despite topical artificial tears, corticosteroids, and bandage contact lens (BCL) for two weeks, his right eye deteriorated with increasing redness and blurred vision and presented with diffuse conjunctival inflammation, severe superficial punctate keratitis, and corneal and limbal epithelial defect. Hence, self-retained cryopreserved AM was applied in the right eye while conventional therapy was continued in the left eye. Placement of self-retained AM for 3-days resulted in resolution of symptoms, reduction in inflammation, and complete re-epithelialization of the corneal and limbal defect with the visual acuity improving from 20/500 to 20/70 in the right eye. In contrast, the visual acuity improved from 20/300 to 20/150 and remained inflamed with conventional therapy in the left eye. One-month post-AM placement, the right eye remained asymptomatic with the visual acuity improved to 20/30 without any additional therapy, whereas the left eye improved to 20/70 with conventional treatment of BCL, loteprednol, and artificial tears. Conclusions and Importance This case suggests application of self-retained AM can be an effective treatment to accelerate the restoration of vision and corneal surface health for acute oGVHD.

A simple, accurate, rapid and precise isocratic stability indicating reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Tobramycin and Loteprednol in combined tablet dosage form. The chromatographic separation was carried out on Zodiac C18 (150 x 4.6mm, 5µ) with a mixture of Phosphate buffer: acetonitrile (60:40%v/v) as a mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 243nm. The retention times were 2.442 and 3.269 min for Tobramycin and Loteprednol respectively. Calibration plots were linear (r2=0.999) over the concentration range of 3.75-22.5 µg/mL for Tobramycin 6.25-37.5µg/mL for Loteprednol. The method was validated for accuracy, precision, specificity, linearity, robustness, LOD and LOQ. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that developed method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Tobramycin and Loteprednol in bulk and tablet dosage form.

To compare the effects of topical loteprednol and fluorometholone in children who underwent strabismus surgery.This is a retrospective observational case series. A total of 60 Korean children who underwent strabismus surgery between January 2016 and September 2016 were included. Patients were prescribed topical loteprednol etabonate 0.5% or fluorometholone 0.1% until 3 weeks after surgery. Four parameters (intraocular pressure [IOP], conjunctival injection, conjunctival inflammation, and patient discomfort) were assessed every week for up to 4 weeks after surgery. Main outcome measures were comparison of parameters between the 2 groups at each following week after surgery. In addition, factors associated with clinically meaningful IOP elevation were evaluated.IOP was significantly elevated at the second and third postoperative week compared with baseline (P = 0.028 and 0.001) in the loteprednol group but not significantly in the fluorometholone group. The mean IOP of the loteprednol group at 1 and 3 weeks after surgery were significantly higher than that of the fluorometholone group (P = 0.032 and 0.017, respectively). Multivariate analysis revealed that age ≤8 years (odds ratio 14.52, 95% confidence interval 1.16-139.05) was associated with IOP21 mmHg. There was no significant difference between the 2 groups in patient discomfort, conjunctival inflammation, and conjunctival injection.Loteprednol and fluorometholone showed similar anti-inflammatory effect after strabismus surgery in children. Loteprednol appeared to have more effect on IOP elevation than fluorometholone, especially in children ≤8 years of age. When treating young patients with loteprednol, clinicians should be aware of IOP elevation.

Mark D Mifflin,1 Brent S Betts,1 P Adam Frederick,2 Jason M Feuerman,3 Carlton R Fenzl,4 Majid Moshirfar,1,5 Brian Zaugg1 1Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah, Salt Lake City, UT, 2The Eye Center, Huntsville, AL, 3Eye Institute of Austin, Austin, TX, 4Eye Surgeons Associates, Bettendorf, IA, 5Hoopes Vision, Draper, UT, USA Purpose: To compare the outcome of photorefractive keratectomy (PRK) and complications in patients treated with either loteprednol etabonate 0.5% gel or prednisolone acetate 1% suspension and fluorometholone (fml) 0.1% suspension.Setting: John A Moran Eye Center, University of Utah, Salt Lake City, UT, USA.Design: Prospective, randomized, partially masked trial.Methods: PRK was performed on 261 eyes of 132 participants. Patients were randomized to a postoperative corticosteroid regimen of either loteprednol etabonate 0.5% gel (loteprednol) or prednisolone 1% acetate suspension followed by fluorometholone 0.1% suspension (prednisolone/fml). Primary outcome measures included incidence and grade of postoperative corneal haze and incidence of increased intraocular pressure of 10 mmHg above baseline, or any intraocular pressure over 21 mmHg. Secondary outcome measures included uncorrected distance visual acuity, best corrected distance visual acuity, and manifest refraction spherical equivalent.Results: The incidence of haze in the first 3 months was 2.6% (3/114 eyes) in the loteprednol group and 4.8% (7/147 eyes) in the prednisolone/fml group and was not statistically significant between groups (P=0.37). The incidence of elevated intraocular pressure was 1.8% (2/114 eyes) in the loteprednol group and 4.1% (6/147 eyes) in the prednisolone/fml group, and was not statistically significant between the groups (P=0.12). The mean 3-month postoperative logMAR uncorrected visual acuity was −0.078±0.10 and −0.075±0.09 in the loteprednol and prednisolone/fml groups, respectively (P=0.83).Conclusion: Postoperative corneal haze and elevated intraocular pressure were uncommon in both treatment arms. There was no statistically significant difference between each postoperative regimen. Refractive results were similar and excellent in both treatment arms. A tapered prophylactic regimen of loteprednol 0.5% gel is equally effective to prednisolone 1%/fml 0.1% after PRK. Keywords: PRK, corticosteroid, fluorometholone, loteprednol, lotemax, wavefront optimized

Mark D Mifflin,1 Brent S Betts,1 P Adam Frederick,2 Jason M Feuerman,3 Carlton R Fenzl,4 Majid Moshirfar,1,5 Brian Zaugg1 1Department of Ophthalmology and Visual Sciences, John A Moran Eye Center, University of Utah, Salt Lake City, UT, 2The Eye Center, Huntsville, AL, 3Eye Institute of Austin, Austin, TX, 4Eye Surgeons Associates, Bettendorf, IA, 5Hoopes Vision, Draper, UT, USA Purpose: To compare the outcome of photorefractive keratectomy (PRK) and complications in patients treated with either loteprednol etabonate 0.5% gel or prednisolone acetate 1% suspension and fluorometholone (fml) 0.1% suspension.Setting: John A Moran Eye Center, University of Utah, Salt Lake City, UT, USA.Design: Prospective, randomized, partially masked trial.Methods: PRK was performed on 261 eyes of 132 participants. Patients were randomized to a postoperative corticosteroid regimen of either loteprednol etabonate 0.5% gel (loteprednol) or prednisolone 1% acetate suspension followed by fluorometholone 0.1% suspension (prednisolone/fml). Primary outcome measures included incidence and grade of postoperative corneal haze and incidence of increased intraocular pressure of 10 mmHg above baseline, or any intraocular pressure over 21 mmHg. Secondary outcome measures included uncorrected distance visual acuity, best corrected distance visual acuity, and manifest refraction spherical equivalent.Results: The incidence of haze in the first 3 months was 2.6% (3/114 eyes) in the loteprednol group and 4.8% (7/147 eyes) in the prednisolone/fml group and was not statistically significant between groups (P=0.37). The incidence of elevated intraocular pressure was 1.8% (2/114 eyes) in the loteprednol group and 4.1% (6/147 eyes) in the prednisolone/fml group, and was not statistically significant between the groups (P=0.12). The mean 3-month postoperative logMAR uncorrected visual acuity was −0.078±0.10 and −0.075±0.09 in the loteprednol and prednisolone/fml groups, respectively (P=0.83).Conclusion: Postoperative corneal haze and elevated intraocular pressure were uncommon in both treatment arms. There was no statistically significant difference between each postoperative regimen. Refractive results were similar and excellent in both treatment arms. A tapered prophylactic regimen of loteprednol 0.5% gel is equally effective to prednisolone 1%/fml 0.1% after PRK. Keywords: PRK, corticosteroid, fluorometholone, loteprednol, lotemax, wavefront optimized

Aim To do a randomized prospective interventional study for comparing the effects of a single subconjunctival triamcinolone acetonide (SCTA) injection to tapering topical loteprednol in patients undergoing phacoemulsification surgery under topical anesthesia. Methods A total of 400 patients were randomized into 2 groups; Group A (200 patients) received 5 mg SCTA at the end of surgery and topical ketorolac tromethamine (0.5%) with ofloxacin (0.3%) combination for 3wk. Group B (200 patients) received tapering topical loteprednol etabonate (0.5%) along with ofloxacin (0.3%) and ketorolac tromethamine (0.5%) for 3wk. Outcomes evaluated were intraocular pressure (IOP), anterior chamber cells/flare and macular oedema postoperatively at 1, 6 and 12wk. Results Baseline parameters were almost similar in both the groups. No statistical difference was seen between the preoperative and postoperative IOP values for Group A (P=0.82) and Group B (P=0.61) and postoperative IOP values in between both groups (P=0.14) at 1wk. Incidence of cells/flare postoperative was statistically not significant (P=0.82) in both groups at all follow up visits. Postoperative macular oedema was not observed at any follow up visit. Conclusion SCTA appears to be an effective alternative to prolong postoperative topical steroid use.

Purpose: To report intraocular pressure (IOP) after use of difluprednate ophthalmic solution 0.05% (Durezol®; Novartis AG, Basilea, Switzerland) post corneal cross-linking (CXL) versus prednisolone (Pred-Forte®; Allergan Inc., Irvine, CA, USA). Methods: A retrospective single-center case series evaluation of 34 keratoconus patients ages 16-“41 (36 eyes) who underwent CXL with Avedro's KXL System® (Avedro Inc; Waltham, MA) between August 2016 and August 2017. Post-CXL, six eyes were given difluprednate and 30 were given prednisolone. IOP was recorded using Reichert model 30 pneumatonometer. Those that exhibited increased IOP at 3 days were given anti-glaucoma medications and changed to fluorometholone or loteprednol. Results: IOP's 3 days' postoperative (24.167 ± 5.23) in the difluprednate group were significantly higher than preprocedure (16.5 ± 2.258). In the prednisolone group, 3 days postprocedure the mean IOP (14.2 ± 3.199) was not significantly higher than preoperatory IOP mean (16.8 ± 4.232). The difference between IOP 3 days' postprocedure and before was 7.667 ± 4.546 for the difluprednate group and 2.567 ± 2.648 for the prednisolone group. These were compared using an unpaired t-test (t value = 3.750 ± 1.297) with P = 0.0007. Discussion: This study shows statistically significant difference in postoperative and preoperative IOP values after the use of difluprednate or prednisolone in young patients postCXL. Measuring the pachymetry on follow-up examinations could help see if changes in corneal thickness affect measured IOP. A controlled prospective double-blind study could confirm a greater increase in IOP following difluprednate versus prednisolone use, but due to the high risk, we do not recommend this study.

Purpose: To compare the efficiency and ocular side-effect profile of topical loteprednol applied to one eye and topical dexamethasone applied to the other eye in the early period on the same patient who has subepithelial infiltrates (SEI).Methods: The patients who developed bilateral SEI following epidemic keratoconjunctivitis (EKC) were applied topical loteprednol on one eye (group 2) and topical dexamethasone on the other (group 1).Results: Decrease in the symptoms was faster in the dexamethasone group, but this difference between the groups was not statistically significant (p = 0.073). Both groups were found to have substantial recurrence. However, the difference between the groups was not statistically significant (p = 0.131).Conclusions: The study has found that in the treatment of SEI, which developed after EKC, statistically similar results can be obtained with loteprednol, which is known to have fewer adverse effects.

Background: Seasonal allergic conjunctivitis (SAC) one of the most common ocular immunological disorder affecting wide population. Various classes of drugs are been used to control allergic inflammation. Traditionally topical glucocorticoids have been used for SAC. However, repeated and continuous use of steroids is associated with various complications like increase in intraocular pressure, posterior sub capsular cataract, increased susceptibility for infections and delayed wound healing. Hence the current emphasis is to prefer topical NSAIDs as they are free from various steroid related complications. As there is paucity of information regarding the comparative efficacy of topical steroids and NSAIDs, the present study was taken up. The main objective was to study the comparative efficacy and safety of three topical NSAIDs: flurbiprofen, diclofenac, ketorolac and the topical steroid loteprednol, in SAC. Methods: A prospective, comparative study enrolled 40 patients for SAC. All study drugs were instilled 4 times daily for 4 weeks. Patients were assessed for objective and subjective parameters of inflammation at baseline and weekly intervals for 4 weeks using four point scales, and also observed for any side effects. The anti-inflammatory action was assessed by the change in mean scores from basal and at various intervals. Results: Loteprednol was more effective than the three NSAIDs, only ketorolac comparable to loteprednol in relieving ocular itching. Study drugs showed good safety and tolerability, with only minimal local side effects. Conclusions: SAC the topical steroid loteprednol was found superior to NSAIDs.

Michelle M Hessen, Sina Vahedi, Chloe T Khoo, Gelareh Vakili, Allen O Eghrari Division of Cornea, Cataract, & External Diseases, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA Purpose: Amantadine use has been temporally associated with bilateral corneal edema in a series of cases; however, its pathophysiological mechanisms have yet to be elucidated. We sought to rule out subclinical Fuchs dystrophy as a contributor, characterize its pattern of corneal edema, and describe the long-term outcome of concurrent topical steroids while resuming amantadine. Patient and methods: After a 44-year-old woman presented with new acute onset bilateral corneal edema, amantadine was discontinued, with clinical improvement. However, neurological decompensation required restarting amantadine, which she did concurrently with topical loteprednol. To determine whether subclinical Fuchs dystrophy might be present, triplet-primed polymerase chain reaction was conducted to measure copy number of the CTG18.1 trinucleotide repeat in TCF4. Specular microscopy and Scheimpflug imaging were conducted and followed for 32 months to assess for resolution and stability. Literature review was conducted to assess for consistency of the clinical phenotype. Results: Corneal edema resolved clinically 4 weeks after discontinuation of amantadine. Serial Scheimpflug imaging demonstrated resolution of posterior and central corneal edema and specular microscopy revealed intracellular opacities with loss of endothelial cell density. Despite resuming amantadine, Scheimpflug imaging and specular microscopy measurements remained stable at 32 months. Triplet-primed PCR of CTG18.1 in TCF4 revealed no trinucleotide repeat expansion. Conclusions: Amantadine-associated corneal edema is characteristically posterior and central and appears unlikely to represent early or subclinical decompensation of Fuchs dystrophy. We describe the unique outcome of continued corneal clearance after restarting amantadine concurrently with steroids, a pattern that has persisted over 32 months to date. Keywords: amantadine, cornea, corneal edema, corneal endothelium, Fuchs dystrophy, Scheimpflug imaging

Purpose. To report degeneration of subbasal corneal nerves and the subsequent neuroregeneration in a case of acute ultraviolet (UV) keratitis, treated with autologous serum eye drops. Methods. Case report. Results. A 37-year-old female presented with ocular discomfort and blurred vision in both eyes, after exposure to UV-C light in a laboratory. On exam, she had bilateral conjunctival injection and superficial punctate keratitis (SPK), worse in the left, consistent with acute, bilateral, but asymmetric UV-C keratitis. She was initially started on antibiotic ointment and lubricant eye drops. On her follow-up visit 3 days later, corneas had persistent SPK bilaterally. Laser scanning in vivo confocal microscopy (IVCM) showed beading of subbasal corneal nerves in the right eye and decreased subbasal corneal nerve density and numerous amputated nerves in the left eye. Autologous serum eye drops 20%, eight times a day, and loteprednol 0.5% ophthalmic solution were commenced in both eyes. Twelve weeks later, her symptoms fully resolved; IVCM revealed near-normal subbasal corneal nerve density in both eyes. Conclusions. IVCM demonstrated dramatic damage to subbasal corneal nerves after brief UV-C exposure. The patient, treated with autologous serum eye drops in both eyes, achieved resolution of symptoms and recovery of subbasal corneal nerves.

Prevention and management of postoperative ocular inflammation with corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) have been evaluated in several randomised controlled trials (RCTs). However, neither consensus regarding the efficacies of different regimens nor established guidelines are currently available. This has resulted in different practice patterns throughout the world. A systematic literature review found that for the management of postcataract inflammation nepafenac produced a positive outcome in three of three RCTs (3/3), as did ketorolac (1/1), bromfenac (7/7), loteprednol (3/3) and difluprednate (6/6), but not flurbiprofen (0/1). A single study found that betamethasone produced inconclusive results after retinal detachment (RD) surgery; ketorolac was effective (1/1) after vitrectomy, but triamcinolone was ineffective (0/1) after trabeculectomy. A two-round Delphi survey asked 28 international experts to rate both the inflammatory potential of different eye surgeries and their agreement with different treatment protocols. They rated trabeculectomy, RD surgery and combined phacovitrectomy as more inflammatory than cataract surgery. Vitrectomies for macular hole or epiretinal membrane were not deemed more inflammatory than cataract surgery. For trabeculectomy, they preferred to treat longer than for cataract surgery (NSAID + corticosteroid three times a day for 2 months vs 1 month). For vitrectomy alone, RD surgery and combined phacovitrectomy, the panel preferred the same treatment as for cataract surgery (NSAID + corticosteroid three times a day for 1 month). The discrepancy between preferred treatment and perception of the eye's inflammatory status by the experts for RD and combined vitreoretinal surgeries highlights the need for RCTs to establish treatment guidelines.

Purpose To analyze current practice patterns in the prevention and treatment of corneal graft rejection for both penetrating keratoplasty (PK) and endothelial keratoplasty (EK) and to compare these patterns with previously reported practices. Methods In 2011, an electronic survey was sent to 670 members of the Cornea Society worldwide addressing the routine postoperative management of corneal transplants at different time points, treatment of various manifestations of corneal graft rejection, and preferred surgical techniques. Results A total of 204 of 670 surveys (30%) were returned and evaluated. All respondents used topical corticosteroids for routine postoperative management and treatment of endothelial graft rejection. Prednisolone was the topical steroid of choice in all clinical scenarios, similar to previous surveys from 1989 to 2004. Use of subconjunctival and systemic steroids increased for many scenarios of probable and definite graft rejection. Routine use of prednisolone decreased by approximately 10% from previous surveys, whereas difluprednate was used in 13% of high-risk eyes during the first 6 months. Dexamethasone, fluorometholone, and loteprednol use remained stable. Adjunctive topical cyclosporine use increased significantly for PK and EK. EK was the preferred technique for endothelial dysfunction, whereas PK and deep anterior lamellar keratoplasty were both used for keratoconus and anterior scars. Most respondents (75%) felt that graft rejection occurs more frequently after PK than after EK. Conclusions Prednisolone remains the treatment of choice for management and treatment of graft rejection; however, since the introduction of difluprednate, its use has declined slightly since the introduction of difluprednate. Despite perceived differences in rejection rates, there were no differences in prophylactic steroid treatment for PK and EK.

Objective. To compare the effects of prednisolone and of loteprednol after combined phacoemulsification and trabecular micro-bypass stent implantation (phaco-iStent).Methods. Patients who underwent phaco-iStent between April 2013 and November 2014 were identified by retrospective chart review. Postoperatively, they received either prednisolone (n=38) or loteprednol (n=58). Baseline data was compared. Primary outcomes including intraocular pressure (IOP) and number of glaucoma medications (NGM) were analyzed at preoperative visit, postoperative day 1, weeks 1-2, weeks 3-4, and months 2-3.Results. Both groups had similar preoperative parameters (p>0.05). The mean IOP spike occurred at postoperative weeks 1-2 with an increase of 2.21 ± 7.30 mmHg in the loteprednol group and 2.54 ± 9.28 mmHg in the prednisolone group. It decreased by weeks 3-4 in both groups and continued to improve at months 2-3. NGM showed significant reduction (p<0.0001) after the surgery and remained stable in both groups. No significant group effect or time-group interaction in IOP and NGM evolution was detected (p>0.05). The proportions of patients needing paracentesis were similar between the two groups.Conclusion. Similar early IOP elevations after combined phaco-iStent occurred with both prednisolone and loteprednol. Facilitated glucocorticoid infusion, altered aqueous humor outflow, and local inflammation may be contributing factors.

Background: Post surgical ocular inflammation is a common happening after the cataract surgery. Topical steroids are the main stay of the treatment. Although it is quite effective in controlling it but it produces severe adverse drug reactions i.e. rise in intraocular pressure and dryness in the eyes. In present study we have compared the two newer topical steroids i.e. loteprednol and difluprednate with prednisolone for the safety issue. Methods: Total n=150 patients of cataract were enrolled in the study. Institutional ethics committee approval was taken. After randomization, patients were allocated into three groups of 50 each. Baseline reading of intraocular pressure and tear film breakup time was recorded. Post operatively examination was done on day 7, 15 and 30 day. The results were compared as prednisolone versus loteprednol, prednisolone versus difluprednate. Results: A. On intraocular pressure 1.prednisolone versus difluprednate statistically significant effect at day 7 (p=0.043), day15 (p=0.010) and at day 30(p=0.036) were there. 2. Prednisolone versus loteprednol- The difference was statistically highly significant at day 7 (0.00), day 15 (p=0.009) and at day 30 th (p=0.00). B. On tear film breakup time-No significant effect on tear film breakup time is observed. Conclusions: Both the newer drugs are much safer as compared to prednisolone for intraocular pressure. As they are equiefficacious to prednisolone their use in post cataract surgery inflammation is recommended.

To compare the outcomes and complications of topical difluprednate 0.05% and loteprednol gel 0.5% after routine cataract surgery.Subjects received either difluprednate emulsion 0.05% (n=30 eyes) or loteprednol gel 0.5% (n=30 eyes) after routine cataract surgery. Topical steroid drops were initiated 3 days before cataract surgery and continued for 2 weeks postoperatively. Anterior chamber (AC) cell grade, corneal edema, corneal pachymetry, visual acuity, ocular surface quality (Oxford scale), and intraocular pressure (IOP) were evaluated at 1 day, 1 week, and 1 month postoperatively.Patients treated with difluprednate or loteprednol had statistically similar resolution of their AC cell grade and corneal edema at 1 day, 1 week, and 1 month postoperatively (P0.05 at each study visit). Difluprednate-treated and loteprednol-treated eyes achieved a mean best-corrected visual acuity of at least 20/25 by 1 week postoperatively (0.055 and 0.061 logarithm of the minimum angle of resolution, respectively; P=0.82). The nasal ocular surface quality at 1 week had improved in loteprednol-treated eyes compared with difluprednate-treated eyes (1.0 vs. 1.9 Oxford score, respectively; P0.001), but similar at all other visits. There was no statistical difference between IOP levels between both treatment groups (P0.05). In the difluprednate-treated group, one patient developed rebound inflammation and two patients developed cystoid macular edema at their 1-month postoperative visit.The anti-inflammatory effect, visual recovery, and IOP of patients using topical difluprednate or loteprednol gel after cataract surgery are equivalent. There may be an additional short-term benefit of loteprednol gel in protecting the ocular surface after cataract surgery.

Purpose: To compare the efficacy and side effects of loteprednol versus fluorometholone after myopic photorefractive keratectomy (PRK). Methods: One hundred and twenty four eyes of 62 patients who underwent PRK were enrolled in this study. One eye of each subject was randomized to receive loteprednol 0.5% and the fellow eye was given fluorometholone 0.1%. Patients were followed up for three months. Results: There was no significant difference in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, corneal haze, intraocular pressure (IOP), and ocular discomfort and redness between groups at the final visit. At 3 months postoperatively, 20/25 or better UDVA was achieved in 95% of the loteprednol group and 92% of the fluorometholone group (P > 0.05). There was neither visually significant corneal haze nor ocular hypertension (IOP rise > 10 mmHg or IOP > 21 mmHg) in any group. Conclusion: The efficacy and side effects of loteprednol 0.5% and fluorometholone 0.1% after myopic PRK are comparable.

Background Blepharokeratoconjunctivitis (BKC) is a type of inflammation of the surface of the eye and eyelids that involves changes of the eyelids, dysfunction of the meibomian glands, and inflammation of the conjunctiva and cornea. Chronic inflammation of the cornea can lead to scarring, vascularisation and opacity. BKC in children can cause significant symptoms including irritation, watering, photophobia and loss of vision from corneal opacity, refractive error or amblyopia. Treatment of BKC is directed towards modification of meibomian gland disease and the bacterial flora of lid margin and conjunctiva, and control of ocular surface inflammation. Although both topical and systemic treatments are used to treat people with BKC, this Cochrane review focuses on topical treatments. Objectives To assess and compare data on the efficacy and safety of topical treatments (including antibiotics, steroids, immunosuppressants and lubricants), alone or in combination, for BKC in children from birth to 16 years. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE ( January 1946 to 11 July 2016), Embase (January 1980 to 11 July 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 11 July 2016. We searched the reference lists of identified reports and the Science Citation Index to identify any additional reports of studies that met the inclusion criteria. Selection criteria We searched for randomised controlled trials that involved topical treatments in children up to 16 years of age with a clinical diagnosis of BKC. We planned to include studies that evaluated a single topical medication versus placebo, a combination of treatments versus placebo, and those that compared two or multiple active treatments. We planned to include studies in which participants received additional treatments, such as oral antibiotics, oral anti-inflammatories, warm lid compresses and lid margin cleaning. Data collection and analysis Two review authors independently screened the results of the literature search (titles and abstracts) to identify studies that met the inclusion criteria of the review and applied standards as expected for Cochrane reviews. We graded the certainty of the evidence using GRADE. Main results We included one study from the USA that met the inclusion criteria. In the study, 137 children aged zero to six years old with blepharoconjunctivitis were randomised to treatment in one of four trial arms (loteprednol etabonate/tobramycin combination, loteprednol etabonate alone, tobramycin alone or placebo) for 15 days, with assessments on days 1, 3, 7 and 15. We judged the study to be at high risk of attrition bias and bias due to selective outcome reporting. The study did not report the number of children with improvement in symptoms nor with total or partial success as measured by changes in clinical symptoms. All children showed a reduction in blepharoconjunctivitis grade score, but there was no evidence of important differences between groups. Visual acuity was not fully reported but the authors stated that there was no change in visual acuity in any of the treatment groups. The study reported ocular and non ocular adverse events but was underpowered to detect differences between the groups. Ocular adverse events were as follows: loteprednol/tobramycin 1/34 (eye pain); loteprednol 4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation); tobramycin 0/34; placebo (vehicle) 0/34. The evidence was limited for all these outcomes and we judged it to be very low certainty. There was no information on clinical signs (aside from grade score), disease progression or quality of life. Authors' conclusions There is no high-quality evidence of the safety and efficacy of topical treatments for BKC, which resulted in uncertainty about the indications and effectiveness of topical treatment. Clinical trials are required to test efficacy and safety of current and any future treatments. Outcome measures need to be developed which can capture both objective clinical and patient-reported aspects of the condition and treatments.

Purpose: The aim of this study was to compare the ocular hypertensive effect of the commercially available Betamethasone, Fluorometholone in Iran and Loteprednol Etabonate in patients undergoing keratorefractive surgery. Methods: In this prospective randomized clinical trial, 300 eyes of 150 patients were included, and patients were randomly assigned to 3 groups and used one of the 3 steroid drops (Betamethasone 0.1%, Fluorometholone 0.1%, and Loteprednol Etabonate 0.5%) after myopic photorefractive keratectomy (PRK). Intraocular pressure (IOP) was measured 2, 4, and 6 weeks post-surgery. Twenty-two mmHg was set as the threshold IOP for starting anti-glaucoma medication and tapering steroid drops. Results: Of 300 eyes from 150 patients over the first 6 postoperative weeks, 2 eyes in Fluorometholone group (2%), 12 eyes in Betamethasone group (12%), and 16 eyes in Loteprednol group (16%) had IOP equal or more than 22 mmHg. Analysis of variance (ANOVA) test showed that the rise in IOP was significantly different between groups in the 2nd and 4th (P ≤ 0.001) postoperative weeks but not at 6th week (P = 0.230). An IOP rise equal or more than 10 mmHg was detected in 13 and 15 eyes in Betamethasone and Loteprednol groups, respectively. None of the eyes in Fluorometholone group had such an IOP rise. Conclusions: Loteprednol and Fluorometholone were associated with the most and least increase in IOP, respectively. The highest pressures were detected 4 weeks after surgery in the Betamethasone and Loteprednol groups and 6 weeks after surgery in the Fluorometholone group. Fluorometholone was the safest among the three examined steroid drops in terms of IOP rise. Keywords: Steroid induced glaucoma, Loteprednol etabonate, Keratorefractive surgery, Photorefractive keratectomy

A 75-year-old male with a right eye history of chronic dry eye syndrome, glaucoma status post tube shunt, and Fuchs dystrophy status post Descemet stripping endothelial keratoplasty followed by penetrating keratoplasty (PKP) presented with a 2.7 × 4.2 mm corneal ulcer, culture positive for Shewanella algae and Klebsiella oxytoca. A topical antibiotic regimen of gentamicin 14 mg/mL and vancomycin 50 mg/mL was administered according to culture sensitivities. There was concurrent use of loteprednol 0.5% (Lotemax Gel, Bausch and Lomb, Rochester, NY, USA) and later addition of erythromycin 0.5% ointment. The corneal ulcer improved with antibiotic therapy but was complicated by poor patient follow-up. Descemetocele formation prompted PKP in the right eye. The graft was successful and visual acuity improved from a low of light perception to maximum of 20/200 Snellen.

Case History A 24 year old farmer presented with bilateral decreased vision of three days duration. There was a history of snake bite on his left arm after which he was taken to a snake charmer at his village for treatment. A traditional eye medicine in the form of a whitish flaky powder was instilled into both his eyes by the snake charmer to keep him “awake”. Two days later he developed pain, redness and reduced vision in both eyes. He was referred to a tertiary care hospital. At presentation the visual acuity in both the eyes was perception of light. There was lid edema and conjunctival necrosis with 360 degree limbal involvement in both eyes. Examination of the right eye revealed the presence of corneal melt with iris prolapse and adhesions at multiple sites between bulbar and palpebral conjunctiva (Figure 1A). The left eye cornea was edematous with large epithelial defect (Figure 1 B). Blood coagulation profile, renal and liver function tests were normal. Prothrombin time was 11 seconds, Partial thromboplastin time 40 seconds,blood urea 24 mg%, creatinine 0.6 mg%, total bilirubin 0.9 mg%, SGOT 10 units/ litre, SGPT 13 units/litre. Topical 5% cefazolin and 0.5% carboxymethyl cellulose (CMC) eye drops were started at hourly intervals. Homatropine hydrobromide 2% and autologous serum 20% eye drops were started four times a day for both eyes. The patient underwent large diameter tectonic keratoplasty in the right eye (Figure 2a & b) with bilateral amniotic membrane transplantation (Figure 3a & b). Postoperatively the patient was advised topical 0.5% CMC and 0.3% gatifloxacin for both eyes. Subsequently,he was started on 0.5% loteprednol and a permanent tarsorrhaphy was performed in the right eye to salvage the graft. At 12 weeks follow up the patient had visual acuity of 6/24 with partially opaque cornea in the left eye (Figure 4 a). Right eye had visual acuity of light perception only with opaque corneal graft (Figure 4 b). Chemical analysis of the powder obtained from the snake charmer revealed it to be potassium nitrite. Figure 1 (a): Right eye on presentation: corneal melt with iris prolapse

Introduction To determine whether there is a statistically significant difference in the decrease in intraocular pressure (IOP) after selective laser trabeculoplasty (SLT) between patients receiving a 5–7 days co-administration of loteprednol versus no loteprednol over the course of 1 year. Methods We conducted a retrospective chart review to evaluate use of loteprednol in patients aged 30–85 years undergoing SLT for open-angle glaucoma at our center over a 3-year period. Results Three hundred and eighteen eyes from 313 patients who underwent a 360° SLT treatment between January 2008 and August 2011 were included in the analysis. Patients who received loteprednol showed a mean reduction of 2.5 (±SE 0.3) mmHg or 11.8% (±1.5%) in IOP versus a mean reduction of 3.2 (±0.6) mmHg or 14.9% (±2.5%) in those not treated with loteprednol. This difference showed a trend toward lower IOP without loteprednol, but this was not statistically significant (p = 0.29). Conclusion Postoperative use of loteprednol does not appear to significantly affect IOP in patients undergoing SLT. A randomized double-blinded study in a larger group of patients would be required to clarify this issue. Until such information is available, we recommend that individual clinical judgment be used regarding whether to use topical steroids in patients undergoing SLT.

Amaninhis30spresentedwithcomplaintsofbilateralblurryvision,eye redness, andheadaches. His ocular history was significant for amotor vehicle crash resulting in likely left optic neuropathy (18 years ago), a procedure performed to change the color of his eyes from brown to blue (4 years ago), and bilateral laser in situ karatomileusis surgery (2 years ago). He was being treated by outside ophthalmologists with loteprednol, nepafenac, timolol, andartificial tears.Hedidnotwearcontact lenses.Hisbest-correctedvisualacuitywas20/20 OD and 20/30OS. Anterior slitlamp examination of both eyes revealed the finding shown in Figure 1. His anterior segment was deep and quiet, and his dilated fundus examination was unremarkable. His intraocular pressure (IOP) was reproducibly higher in the right eye on 3 separate visits, averaging 20mmHg OD and 13 mmHg OS. His central corneal thickness was 496 μm OD and 480 μm OS. His endothelial cell count was 1681 cells/mm2 OD and 2045 cells/mm2 OS. Figure 1. External photograph of patient’s right eye on presentation.

Introduction Senile cataract is the most common cause of visual impairment. Removal of cataract and implantation of intraocular lens implantation (IOL) is the main surgical approach for cataract. The major block in quick visual rehabilitation of the patient is post-operative inflammation. To limit post-operative inflammation corticosteroids drugs are used in routine prophylactically. Topical prednisolone acetate 1% and betamethasone 0.1% remain gold standard to control post-operative inflammation but newer drugs like difluprednate, loteprednol are also effective in controlling inflammation. Aim To study the efficacy of difluprednate ophthalmic emulsion and prednisolone acetate ophthalmic suspension on Post-operative inflammation in cataract surgery (clear corneal phacoemulsification with foldable IOL). Materials and methods This study was carried out on 100 patients having visually significant cataract requiring surgery, clear corneal phacoemulsification with foldable intraocular lens implantation was done in all patients. Patients were randomly divided into two groups. In group A topical 1% prednisolone acetate ophthalmic suspension was administered six times a day Post-operatively. In group B 0.05% difluprednate ophthalmic emulsion was administered six times a day post-operatively. Efficacy of drug was evaluated in terms of decrease in ocular pain, anterior chamber reaction in the form of aqueous cells and flare and final visual acuity at 4 weeks. Results In this study, 92% of patients in group A and 90% of patients in group B had BCVA 6/6. None of the patients in group A had ocular pain. In group B, 96% patients had no ocular pain. Remaining 4% had mild discomfort but required no medication. 98% of patients in group A and 100% of patients in group B presented with clearance of aqueous cells at the end of study. Only 2% of patients in group A had showed cell score (±). Conclusion Though prednisolone acetate has been the gold standard anti inflammatory agent, 0.05% Difluprednate ophthalmic emulsion is equally effective in treatment of post-operative inflammation. Difluprednate have added an advantage of uniform drug dosage and absence of harmful preservative.

Purpose Conjunctival adherence of a tick is an uncommon event with few reports previously cited in the literature. We report a unique case of tick penetration, specifically a black-legged deer tick ( Ixodes scapularis ), into the conjunctiva. Observations This patient experienced a 3-week history of unilateral mild ocular pain, decreased vision, and pigmented lesion of her right eye. Slit lamp examination demonstrated a tick attached to the conjunctiva. Pathology confirmed the insect exoskeleton. Visual appreciation of the tick demonstrated probable deer tick larval stage given the shape, size, pigmentation pattern and geographic location of the specimen. Polymyxin-trimethoprim eye drops were prescribed for use three times daily and loteprednol twice daily. Conclusions and importance Despite the low risk for Lyme disease, which is endemic to the Adirondack region where the patient was affected, doxycycline was prescribed for prophylaxis. In any case of suspected tick penetration to the ocular surface, immediate ophthalmologic consultation and prompt removal via the method mentioned above is recommended, as well as attention paid to the Infectious Diseases Society of America guidelines regarding prophylaxis.

Ocular corticosteroids can cause elevations in intraocular pressure (IOP). The purpose of this study was to characterize the timing and severity of IOP elevations in patients receiving loteprednol etabonate 0.5% or loteprednol etabonate 0.5%/tobramycin 0.3%.A retrospective chart review was conducted at 5 academic and private practices. Any patient who experienced an elevation in IOP ≥5 mm Hg while using loteprednol etabonate or loteprednol etabonate/tobramycin was eligible for inclusion in the study. Data collected included patient demographics, medical and ophthalmic history, concomitant medications, reason for treatment, IOP, and medical and surgical interventions.Fifty patients experienced IOP elevations after use of topical loteprednol etabonate and were included in the study. The mean (standard deviation [SD]) patient age was 58.8 (20.3) years and 66% were women. The most common reasons for prescribing loteprednol etabonate were dry eye (30%), postoperative therapy (22%), and allergic conjunctivitis (16%). Before treatment, 28% of patients had a history of open-angle glaucoma or ocular hypertension. Mean (SD) IOP before treatment was 15.5 (3.2) mm Hg and increased to a mean (SD) of 24.7 (6.5) mm Hg, a statistically significant increase of 9.2 (SD: 5.8; range: 5-29) mm Hg (P0.0001). The median duration of treatment with loteprednol etabonate at the time of observed IOP elevation was 55 days (range: 3 days to 3 years). Twenty-four percent of patients required IOP-lowering medications and 8% required surgery to control the elevated IOP.Alternatives to corticosteroids should be considered when long-term treatment is required for an ocular surface condition.

A facile synthesis of the side chain of loteprednol etabonate, namely, chloromethyl-17α-[(ethoxycarbonyl))oxy]-11β-hydro of loteprednol etabonate, viz., chloromethyl-17α-[(ethoxycarbonyl))oxy]-11xy-3-oxoandrosta-1,4-diene-17β-carboxylate – an ocular soft corticosteroid, has been described starting from a 20-oxopregnane, namely, 3β-acetoxy-pregn-5(6),16(17)-diene-20-one (16-dehydropregnenolone acetate, i.e., 16-DPA) using our recently developed metal-mediated halogenation as a key reaction.

This retrospective, clinical comparative analysis describes differences in clinical signs and symptoms and medication tolerability between those patients who receive topical corticosteroids prior to initiation of topical cyclosporine 0.5% emulsion (tCSA) therapy for chronic dry eye disease (CDED) and those who received tCSA and were not first induced with corticosteroid drops. tCSA is the only approved medication for CDED. Stinging is the most common side effect of tCSA and reason for tCSA discontinuation. This analysis describes an effective pharmacologic means to reduce tCSA stinging and subsequent discontinuation.Thirty-six consecutive patients were initially treated with loteprednol etabonate (LE) 0.5% (Lotemax; BauschLomb) for a period ranging from 2 to 16 months prior to institution of concomitant tCSA (Restasis™; Allergan). Clinical parameters (fluorescein staining, conjunctival redness, tear meniscus) were compared over a period of 6 months to a second cohort of 36 consecutive patients who were initially prescribed continuous tCSA without concomitant LE pretreatment. Patients in the LE pretreatment group discontinued LE after 3-6 months of concomitant therapy while continuing tCSA therapy.Of the 36 LE pretreatment patients, only 2 developed significant stinging (5.5%) and 1 discontinued the use of tCSA because of stinging (2.8%). Of the patients without LE pretreatment, 8 developed stinging (22%) and 3 discontinued tCSA as a result (8.3%). The intergroup P value was significant for severe stinging (0.02) and for tCSA discontinuation because of severe stinging (0.04). Patients in the LE pretreatment group had no statistically significant differences in preenrollment disease severity or demographics (P range from 0.19 to 0.59) compared with the group without pretreatment.Topical corticosteroid preparation of the ocular surface in CDED with LE induction therapy may reduce discomfort from subsequent long-term maintenance topical medications, particularly tCSA. This analysis describes a readily available induction and maintenance pharmacologic strategy to reduce tCSA stinging and subsequent discontinuation.

A 49-year-old woman, known case of diffuse large B-cell lymphoma, presented with complaints of floater in both eyes since 3 days. On examination, visual acuity was 0.18 logMAR in both eyes. Indirect ophthalmoscopy revealed presence of vitreous clumps. Vitreous biopsy was done and the histopathological report suggested a diagnosis of ocular lymphoma. The patient was treated with weekly injections of intravitreal methotrexate in both eyes. The patient developed severe photophobia, watering, redness and diminution of vision in the both eyes 2 days following the fifth dose of intravitreal methotrexate. Severe limbitis with annular corneal epitheliopathy and corneal haze was noted on slit-lamp examination. The patient was started on topical lubricants, antibiotic, ciclosporin, loteprednol, folinic acid and oral folic acid. Complete resolution was noted at 2-week follow-up. The patient, however, refused further injections and was kept on close follow-up to look for recurrence of the disease.

The treatment of ocular inflammation continues to be a challenge. Topical corticosteroids are effective in reducing ocular inflammation but are limited by adverse events including elevation of intraocular pressure, development of cataracts, glaucoma and inhibition of wound healing with associated risk of infection. Loteprednol etabonate (LE) is a unique C-20 ester corticosteroid designed to produce a predictable therapeutic effect with a low incidence of side effects. Zylet (LE/T) a combination of LE and tobramycin (T) is indicated for the treatment of steroid-responsive ocular inflammatory conditions in which there exists either superficial bacterial ocular infection or a potential risk of bacterial infection.The current review of the literature (Medline and the Cochrane Library, 1996 - 2009) examines the safety and efficacy of LE/T in the treatment of ocular inflammation.Studies with either LE or LE/T indicate that LE has a lower risk of IOP elevation compared with C-20 ketone corticosteroids owing to its rapid de-esterification to inactive metabolites. LE also lacks the ability to form Schiff base intermediates with lens proteins, a common first step in cataractogenesis. LE/T was noninferior to dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis.LE/T may be a safer treatment option for ocular inflammation in which there is risk of superficial bacterial infections.

To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension.Three hundred six healthy volunteers received either loteprednol etabonate/tobramycin (n = 156) or dexamethasone/tobramycin (n = 150) at 4-hour intervals 4 times a day in both eyes for 28 days in this randomized, double-masked, multicenter, parallel-group trial. IOP, visual acuity (VA), and ocular health were assessed at all study visits (days 1, 3, 8, 15, 22, and 29), whereas undilated direct ophthalmoscopy was completed at the baseline and final visits. Adverse events (AEs) were assessed at all follow-up visits.The number of subjects experiencing IOP increases ofor=10 mm Hg from baseline at any study visit for the loteprednol etabonate/tobramycin group (3 subjects, 1.95%) was significantly lower than that for the dexamethasone/tobramycin group (11 subjects, 7.48%; P = 0.0280), as were mean changes from baseline IOP (P0.05 at all visits). The lowest VA recorded for any subject at any visit was 20/40 and reductions ofor=2 lines at any visit were observed in 14 (4.55%) eyes for loteprednol etabonate/tobramycin and in 23 (7.82%) eyes for dexamethasone/tobramycin (P = 0.1257). Both treatments were well tolerated.Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.

To evaluate the safety and efficacy of topical loteprednol etabonate (LE) 0.5% compared with cyclosporine A (CsA) 0.05% for the prophylaxis and treatment of dry eye syndrome (DES) after hematopoietic stem cell transplantation (HSCT).Seventy-five patients were randomized to LE (n = 76 eyes of 38 patients) or CsA (n = 74 eyes of 37 patients) pre-HSCT. Lissamine green and fluorescein staining, tear break-up time, tear osmolarity (Osm), Schirmer score (Sch), intraocular pressure, visual acuity, and Ocular Surface Disease Index were assessed pre-HSCT, 3, 6, 9, and 12 months post-HSCT.There were no differences in DES incidence (P = 0.22; log-rank test) or progression (P = 0.41; log-rank test) between the 2 treatment arms during the course of the study. Among eyes with no DES at enrollment, the Kaplan-Meier analysis yielded a 90% rate of DES development in cyclosporine-treated eyes and a 79% rate of DES development in LE-treated eyes by 12 months post-HSCT. The Kaplan-Meier analysis of eyes with DES at enrollment demonstrated a 38% rate of disease progression among cyclosporine-treated eyes and a 26% rate of disease progression among loteprednol-treated eyes by 12 months. No patient in either group had an elevation of 10 mm Hg or greater from baseline at any study visit, and no patients had their treatment discontinued for elevation in intraocular pressure.Pre-HSCT initiation of LE 0.5% appears to be safe and may be as effective as CsA 0.5% for the treatment and prophylaxis of DES following HSCT.

Validation of an analytical method for impurities and degradation products in an active pharmaceutical ingredient is important to assessment of quality and safety in a new pharmaceutical product. In the present study, a high-performance liquid chromatographic method was validated to evaluate purity of loteprednol etabonate (LE). LE and its four related substances, major process impurities and degradation products (PJ-90, PJ-91, LE-11-keto and LE-methyl ester) were well resolved using a phenyl-stationary phase under isocratic conditions. Two photo-degradation products were identified as chloromethyl 17alpha-ethoxycarbonyloxy-11beta-hydroxy-5alpha-methyl-2-oxo-19-norandrosta-1(10),3-diene-17beta-carboxylate and chloromethyl 17alpha-ethoxycarbonyloxy-11beta-hydroxy-1-methyl-3-oxo-6(5-->10alpha)-abeo-19-norandrosta-1,4-diene-17beta-carboxylate. A photo-degradation product, chloromethyl 1beta,11beta-epoxy-17alpha-ethoxycarbonyloxy-2-oxo-10alpha-androsta-4-ene-17beta-carboxylate, was not abundant by ultraviolet detector. The risk depending on only ultraviolet detection should be noted. Calibration curves for PJ-90, PJ-91, LE-11-keto and LE-methyl ester showed linearity over the range of 0.05-2.0% levels in LE with correlation coefficient of 0.999. Accuracy (n = 3) at the concentration of 0.5% level in LE for PJ-90, PJ-91, LE-11-keto and LE-methyl ester were 2.0, 2.0, 2.3 and 2.0%, respectively. Intra-day repeatability (n = 6) at the concentration of 0.5% level in LE for PJ-90, PJ-91, LE-11-keto and LE-methyl ester were 1.4, 1.4, 1.8 and 1.4%, respectively. The lower limits of detection for PJ-90, PJ-91, LE-11-keto and LE-methyl ester were 0.002, 0.001, 0.004 and 0.003% levels in LE, respectively.

Purpose To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance. Design Randomized, double-masked, placebo-controlled clinical trial. Methods Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms. Results In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported. Conclusion The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.

Purpose: To compare the efficacy of a topical nonsteroidal antiinflammatory agent (ketorolac tromethamine ophthalmic solution 0.5%) and a topical steroid (loteprednol etabonate ophthalmic suspension 0.5%) in controlling inflammation after cataract surgery. Setting: Magill Research Center for Vision Correction, Storm Eye Institute, Medical University of South Carolina, Charleston, South Carolina, USA. Methods: Sixty patients were prospectively and randomly assigned to receive topical treatment with ketorolac tromethamine ophthalmic solution 0.5% or loteprednol etabonate ophthalmic suspension 0.5% starting the day after routine phacoemulsification for cataract extraction. Both patient and investigator were masked to treatment. All patients had uneventful small-incision phacoemulsification with placement of a foldable posterior chamber intraocular lens (IOL). Patients used 1 of the 2 antiinflammatory agents 4 times a day starting 24 hours after surgery. Signs and symptoms of inflammation as documented by external slitlamp examination, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated on postoperative days 1, 4, 7, and 30. Results: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements or in IOP between groups. No patient in either group was removed from the study for lack of treatment efficiency. Conclusions: Ketorolac tromethamine ophthalmic solution 0.5% was as effective as loteprednol etabonate ophthalmic suspension 0.5% in reducing inflammation after routine phacoemulsification and IOL implantation. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

To evaluate whether levels of corneal subbasal nerve fiber length (SNFL) in dry eye disease (DED) could prognosticate the level of improvement in signs and symptoms after treatment.Phase IV, double-masked, randomized clinical trial.Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls.Patients with DED were randomized to receive topical artificial tears, loteprednol etabonate 0.5%, or loteprednol etabonate 0.5%/tobramycin 0.3% twice daily for 4 weeks. At baseline, in vivo confocal microscopy of central cornea was performed in both eyes. Patients with DED were divided into 2 subgroups: those with low baseline SNFL and those with near-normal baseline SNFL for this purpose (the cutoff point: the mean SNFL in controls minus 2 standard deviations). Clinical signs and symptoms at baseline and after 4 weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups.Symptom questionnaires, corneal fluorescein staining (CFS), conjunctival staining with lissamine green, tear break-up time, Schirmer's test, and SNFL.In patients with DED, baseline SNFL (17.06±5.78 mm/mm(2)) was significantly lower than in controls (23.68±3.42 mm/mm(2), P = 0.001). In the artificial tear and loteprednol groups, although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL (16.84 mm/mm(2)), subjects with near-normal baseline SNFL (≥16.84 mm/mm(2)) showed significant improvement in both symptoms and CFS score (all P0.05). In the loteprednol/tobramycin group, no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL.Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL. Consideration of SNFL may assist in explaining the variability of patients' response to DED therapy.

Objective To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis. Design Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration. Participants A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated. Intervention All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days. Main outcome measures Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured. Results A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE ( P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively). Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment. Conclusions Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.