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Kamran Hosseini,1 Subba Gollamudi,2 Harvey Reiser,3 Tom Walters,4 Richard L Lindstrom5 1Surface Ophthalmics, Pleasanton, CA, USA; 2VRF Eye Specialty Group, Memphis, TN, USA; 3Eye Care Specialists, Kingston, PA, USA; 4Texan Eye, PA — Keystone Research, Austin, TX, USA; 5Minnesota Eye Consultants, Bloomington, MN, USACorrespondence: Kamran Hosseini, Surface Ophthalmics, Inc, 5000 Hopyard Road, Ste. 402, Pleasanton, CA, 94588, USA, Email khosseini@surfaceophthalmics.comPurpose: To compare the preservative-free corticosteroid 0.2% betamethasone sodium phosphate BID (SURF-201) to vehicle BID in patients undergoing routine cataract surgery.Methods: Phase 2, multicenter, randomized (1:1 ratio), double-masked, vehicle-controlled, parallel-group study in patients scheduled for uncomplicated cataract surgery without the aid of a femtosecond laser. Subjects instilled topical medications for 16 days beginning the day before cataract surgery (Day − 1), 1 dose administered at least 1 hour prior to cataract surgery (on Day 0) and 1 dose on the evening after cataract surgery, and then 2 doses administered each day through Day 15; patients were re-evaluated on Days 22 and 32 to ensure no rebound inflammation. Primary outcome was the difference in the proportion of subjects with anterior chamber cell (ACC) grade 0 between the two groups at Day 15. Secondary outcomes included pain scores and overall safety.Results: There was a statistically significant difference (P=0.004) in the proportion of subjects in the SURF-201 treatment group with an ACC grade of 0 at Day 15 (n=22/39 [56.4%]) compared to subjects in the vehicle treatment group (n=9/43 [20.9%]). There was no statistically significant difference (P=0.528) in the proportion of subjects in the SURF-201 treatment group who had a visual analog scale pain score of 0 at Day 15 (n=35/38 [89.7%]) compared to subjects in the vehicle group (n=33/40 [82.5%]). A slightly higher incidence of adverse events occurred in subjects in the SURF-201 treatment group (n=27/40 [67.5%]) compared to the vehicle treatment group (n=23/43 [53.5%]).Conclusion: SURF-201 is an effective topical, preservative-free corticosteroid when dosed BID for the treatment of postoperative inflammation and prevention of pain in a post-cataract population.Keywords: cataract, postoperative inflammation, corticosteroid, betamethasone sodium phosphate, preservative-free

The current work deals with the fractional forms of EW and modified EW equations in the conformable sense and their exact solutions. In this respect, by utilizing a traveling wave transformation, the governing space-time fractional models are converted to the nonlinear ordinary differential equations (NLODEs); and then, the resulting NLODEs are solved through an effective method called the exp(−ϕ(ϵ))-expansion method. As a consequence, a number of exact solutions to the fractional forms of EW and modified EW equations are generated.

The aim of this paper is to obtain the exact solutions of the strain wave equation applied for illustrating wave propagation in microstructured solids. The effective Kudryashov and functional variable methods along with the symbolic computation system have been used to accomplish the purpose.

Kamran Hosseini,1 Thomas Walters,2 Robert DaVanzo,3 Richard L Lindstrom4 1InSite Vision Inc., Alameda, CA, 2Texan Eye, Austin, TX, 3Cornerstone Health Care, High Point, NC, 4Minnesota Eye Consultants, Bloomington, MN, USA Purpose: The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery.Methods: A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15.Results: At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P

Kamran Hosseini,1 Richard L Lindstrom,2,3 Gary Foulks,4 Kelly K Nichols5 1InSite Vision, Alameda, CA, 2Minnesota Eye Consultants, 3Department of Ophthalmology and Visual Neurosciences, University of Minnesota Medical School, Minneapolis, MN, 4Department of Ophthalmology and Vision Science, School of Medicine, University of Louisville, Louisville, KY, 5School of Optometry, University of Alabama at Birmingham, Birmingham, AL, USA Purpose: To evaluate the clinical efficacy and safety of a 1% azithromycin–0.1% dexamethasone combination in DuraSite (“combination”) compared to 0.1% dexamethasone in DuraSite, 1% azithromycin in DuraSite, and vehicle in the treatment of subjects with blepharitis.Materials and methods: This was a Phase III, double-masked, vehicle-controlled, four-arm study in which 907 subjects with blepharitis were randomized to combination (n=305), 0.1% dexamethasone (n=298), 1% azithromycin (n=155), or vehicle (n=149). Ten study visits were scheduled: screening visit, days 1 and 4 (dosing phase) and 15, and months 1–6 (follow-up phase). On day 1, subjects applied one drop of the study drug to the eyelid of the inflamed eye(s) twice daily, and continued with twice-daily dosing for 14 days. After completing 14 days of dosing, subjects were followed for 6 months for efficacy and safety.Results: A total of 57 subjects (6.3%) had complete clinical resolution at day 15: 25 (8.2%), 17 (5.7%), 8 (5.2%), and 7 (4.7%) subjects in the combination-, 0.1% dexamethasone-, 1% azithromycin-, and vehicle-treatment groups, respectively. The combination was superior to 1% azithromycin and vehicle alone, but not to 0.1% dexamethasone alone. Mean composite (total) clinical sign and symptom scores improved in all four treatment groups during the posttreatment evaluation phase for the intent-to-treat population, but outcomes were superior when a drop containing 0.1% dexamethasone was utilized. Clinical response was noted as early as day 4, and persisted as long as 6 months. Most adverse events were considered mild in severity and not related to the study drug.Conclusion: A higher percentage of subjects in the combination group achieved complete clinical resolution of the signs and symptoms of blepharitis at day 15 than with 1% azithromycin and vehicle, but outcomes were similar to treatment with 0.1% dexamethasone alone. The combination was well tolerated. Keywords: blepharitis, dexamethasone, azithromycin, eyelid inflammation

Kamran Hosseini,1,2 Judith Hutcheson,1 Richard L Lindstrom3–5 1Clinical Affairs, 2Regulatory Affairs, InSite Vision Incorporated, Alameda, CA, USA; 3Minnesota Eye Consultants, Bloomington, MN, USA; 4University of Minnesota Department of Ophthalmology, Minneapolis, MN, USA; 5University of California, Irvine Gavin Herbert Eye Institute, Irvine, CA, USA Purpose: The purpose of this study was to evaluate the clinical and antimicrobial efficacy and safety of ISV-502 (1.0% azithromycin and 0.1% dexamethasone) compared to 1.0% azithromycin or 0.1% dexamethasone in the treatment of subjects with blepharoconjunctivitis. Patients and methods: Patients with verified blepharoconjunctivitis were randomized to receive ISV-502 (Group 1; n=140), 1.0% azithromycin alone (Group 2; n=141), or 0.1% dexamethasone alone (Group 3; n=136). Bacterial cultures were obtained from the conjunctiva and eyelid. Treatment was instilled in both eyes twice daily at 12-hour intervals for 14 days. The primary endpoint was complete resolution of clinical signs and symptoms at Day 15. The secondary endpoint was complete bacterial eradication at Day 15 among subjects with positive bacterial cultures at baseline. Results: Significantly more Group 1 subjects met the primary endpoint (27.1%) than those in Group 2 (15.6%; P=0.028), but not compared to Group 3 (23.5%; P=0.581). Significantly more Group 1 patients (60%) had complete bacterial eradication at Day 15 compared with Group 3 (40.2%; P=0.007), but there was no difference compared with Group 2 (66.3%; P=0.306). Adverse events were reported in about 25% of the subjects, with an equal distribution among treatment arms; the most common adverse event was irritation at the instillation site. Visual acuity and intraocular pressure differences were not statistically significant, but did show age and sex differences between groups. Conclusion: ISV-502 is effective in the treatment of blepharoconjunctivitis as evaluated by clinical cure and bacterial eradication scores. ISV-502 was superior to 1.0% azithromycin in clinical cure and superior to 0.1% dexamethasone in bacterial eradication. Keywords: blepharitis, inflammation, eye

Afshin Shafiee,1 Lyle M Bowman,2 Eddie Hou,2 Kamran Hosseini1,3 1Preclinical, 2Development, 3Clinical, InSite Vision, Alameda, CA, USA Purpose: To compare the aqueous humor (AH) and iris-ciliary body (ICB) concentration of bimatoprost in rabbit eyes treated with ISV-215 (0.03% bimatoprost formulated in DuraSite) with the marketed product bimatoprost 0.03% ophthalmic solution. Methods: The left eye of rabbits received a single topical instillation of either ISV-215 (n = 32 eyes) or bimatoprost 0.03% (n = 32 eyes). At predetermined time points, levels of bimatoprost and bimatoprost acid in the AH and the ICB were quantified by HPLC-MS/MS. Results: Both bimatoprost and bimatoprost acid were detected in the AH and the ICB within 15 minutes of dosing. Bimatoprost acid concentrations in both compartments were markedly higher than bimatoprost. There was a statistically significant (P < 0.01) increase in the concentration of the prodrug in the AH and its acid form in the ICB in animals treated with ISV-215 compared to bimatoprost 0.03%. In the ISV-215-treated rabbit eyes, the highest concentrations of bimatoprost and bimatoprost acid were in the ICB and AH, respectively, while in the bimatoprost 0.03%-treated eyes, no differences in the drug content of the selected ocular tissues were observed. Conclusions: Bimatoprost 0.03% formulated in DuraSite has superior ocular distribution and area under the curve compared to bimatoprost 0.03% in rabbit eyes. This improvement in the pharmacokinetic parameters of ISV-215 may provide us with a better platform to optimize a bimatoprost formulation that offers the same degree of efficacy in lowering intraocular pressure and improved therapeutic index in glaucomatous patients by lessening the ocular side effects associated with long-term use of topical prostaglandin F2α analogs. Keywords: drug delivery, intraocular pressure, glaucoma, aqueous humor, prostaglandin (PGF2α) analogs

This paper explores the evolutionary behavior of some specific waves for a Generalized Hirota Bilinear (GHB) equation with applications in modern sciences. More precisely, the linear superposition principle is first adopted to construct the resonant multi-wave of the GHB equation. Through the resonant N-wave and some particular computations, positive multi-complexiton to the governing model is then extracted with the use of computational packages. Furthermore, after deriving nonclassical Lie symmetries and their corresponding invariant solutions, Conservation Laws (CLs) for the GHB equation are formally constructed based on a general method developed by Ibragimov. The propagation dynamics of resonant double- and triple-waves as well as positive single- and double-complexitons are examined in detail by considering several case studies. The present results demonstrate how adjusting the nonlinear parameter can be used to control specific waves in nonlinear systems. [ABSTRACT FROM AUTHOR]

Let f : {0, 1}n → {0, 1} be a boolean function. Its associated XOR function is the two-party function f(x, y) = f(x y). We show that, up to polynomial factors, the deterministic communication complexity of f is equal to the parity decision tree complexity of f. This relies on a novel technique of entropy reduction for protocols, combined with existing techniques in Fourier analysis and additive combinatorics.

Let G be a finite Abelian group and A a subset of G. The spectrum of A is the set of its large Fourier coefficients. Known combinatorial results on the structure of spectrum, such as Chang's theorem, become trivial in the regime |A|=|G|α whenever α≤c, where c≥1/2 is some absolute constant. On the other hand, there are statistical results, which apply only to a noticeable fraction of the elements, which give nontrivial bounds even to much smaller sets. One such theorem (due to Bourgain) goes as follows. For a noticeable fraction of pairs γ1,γ2 in the spectrum, γ1+γ2 belongs to the spectrum of the same set with a smaller threshold. Here we show that this result can be made combinatorial by restricting to a large subset. That is, we show that for any set A there exists a large subset A′, such that the sumset of the spectrum of A′ has bounded size. Our results apply to sets of size |A|=|G|α for any constant α>0, and even in some sub-constant regime.

The present paper explores the dynamics of ion‐acoustic solitary waves (IASWs) within an unmagnetized, highly relativistic quantum plasma containing positive and negative ions alongside electrons, employing the quantum hydrodynamic model. The treatment accounts for the inertial characteristics of negative and positive ions, considering electrons as inertialess. The nonlinear nature of quantum IASWs is investigated through the derivation of the Korteweg–de Vries equation using the reductive perturbation method. The investigation highlights how wave propagation characteristics, whether compressive or rarefactive, are substantially modulated by several parameters, such as the quantum diffraction parameter (H), relativistic effects (u0/c), equilibrium density (p), and ion mass ratio (Q). The analysis identifies the existence of both slow and fast wave modes, heavily influenced by the relativistic parameters involved. Our findings have significant implications for the understanding of both laboratory and space plasmas, especially in contexts where negative ions are present. [ABSTRACT FROM AUTHOR]