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PurposeTo evaluate 24-h efficacy of travoprost/timolol fixed combination (TTFC) vslatanoprost/timolol fixed combination (LTFC) in exfoliative glaucoma (XFG).DesignA prospective, single-masked, crossover, active-controlled, randomized 24-h comparison.MethodsAfter up to a 6-week medicine-free period, XFG patients were randomized to either TTFC or LTFC for 3 months, dosed each evening, and then changed to the opposite treatment for another 3 months. At the end of the washout, and both treatment periods, a 24-h intraocular pressure (IOP) curve was measured.ResultsIn total, 40 patients completed the study. The TTFC group showed a lower mean absolute 24-h IOP (18.7±2.6 vs19.6±2.6 mm Hg, P<0.001), maximum IOP (20.5±2.6 vs21.5±2.6 mm Hg, P<0.001) and 24-h IOP range (3.4±1.3 vs4.1±1.6 mm Hg, P=0.01). At individual time points, TTFC showed reduced IOPs compared with LTFC, after a Bonferroni correction, at 1000, 1800, and 2200 hours (P0.04). No statistical differences existed at hours: 0600, 1400, and 0200 (P0.05) and for the minimum IOP (P=0.09).ConclusionsThis study suggests that evening-dosed TTFC may provide greater 24-h IOP reduction, primarily at the 1800 hours time point, compared with LTFC in XFG. [ABSTRACT FROM AUTHOR]

AimsTo compare supine nighttime intraocular pressure measurements with Perkins applanation tonometry to 24-h sitting intraocular pressures with Goldmann applanation tonometry.MethodsA prospective, untreated, uncontrolled, observational cohort of qualified consecutive ocular hypertensive or primary open-angle glaucoma patients. Patients underwent sitting intraocular pressure measurements over 24-h by Goldmann and patients had their supine nighttime intraocular pressure measurements by Perkins.ResultsIn 100 completed patients, the mean intraocular pressure at 1000, 2200, 0200 and 0600 hours while sitting was 22.5±3.7 mm Hg, and in the supine position, 23.5±4.3 mm Hg (P<0.001). The mean sitting Goldmann intraocular pressures across the three daytime points was 23.3±3.4 mm Hg and across three nighttime points was 21.5±4.0 mm Hg (P<0.001). In contrast, the mean daytime sitting Goldmann intraocular pressure was not different than the mean nighttime supine intraocular pressure evaluated with Perkins (22.8±4.4 mm Hg, P=0.07). However, only 70% of patients were within 1.0 mm Hg of the highest daytime reading for all nighttime supine and sitting intraocular pressures.ConclusionThis study suggests that with Perkins applanation tonometry the untreated mean supine intraocular pressures are not higher at night than daytime sitting Goldmann applanation tonometry. However, the highest daytime sitting intraocular pressure measurement does not consistently predict the highest nighttime sitting or supine intraocular pressure value. [ABSTRACT FROM AUTHOR]

PurposeTo assess the cost-effectiveness of latanoprost or timolol in glaucoma treatment in Norway, Sweden, Denmark (Scandinavia) and the United Kingdom (UK).MethodsA Markov model was constructed to perform a cost-effectiveness analysis. Health states were ‘stable’ and ‘progressed’ glaucoma, and transition probabilities for both primary open-angle and exfoliation glaucoma were derived from the medical literature. Practice patterns were obtained from surveys completed by 54 ophthalmologists geographically dispersed throughout each country. Country specific unit costs were used for medications, patient visits, diagnostics, and therapeutic procedures.ResultsOver the life of the model latanoprost was less expensive than timolol by 5.3–7.6% (Scandinavia) and 2.1% (UK). Following adjustments, therapy in the original timolol-treated cohort was slightly more effective in each country with a difference in 0.003–0.015 years to progression of glaucoma existing between latanoprost. This may have resulted from the model design, which reflected that physicians ultimately control most patients' glaucoma over 5 years by adding or changing therapy. The associated incremental cost-effectiveness ratios for latanoprost vstimolol generated by the Scandinavian and the UK models, respectively, were: Norway 351 396 NOK; Sweden 988 985 SEK; Denmark 351 641; and the UK 4751 GBP.ConclusionsOver 5 years, in the UK timolol is the cost-effective option, whereas in Scandinavia latanoprost may be the cost-effective alternative to timolol.Eye (2009) 23, 132–140; doi:10.1038/sj.eye.6702964; published online 24 August 2007 [ABSTRACT FROM AUTHOR]

PurposeTo determine the incidence of glaucomatous progression at mean intraocular pressure (IOP) levels in patients with ocular hypertension (OHT).MethodsA retrospective, multicentre, cohort analysis of 230 OHT patients with 5 years of follow-up evaluated for risk factors associated with progressive optic disc and visual field loss to determine the incidence of glaucomatous progression.ResultsForty percent of patients with IOPs 24 mmHg, 18% of patients with IOPs of 21–23 mmHg, 11% of patients with IOPs with 18–20 mmHg, and 3% of patients with IOPs of 17 mmHg progressed to glaucoma. The mean IOP was 19.8±2.4 mmHg in the stable group and 21.7±2.6 mmHg in the progressed group (P=0.0004). The highest average peak IOP was 23.4±4.0 mmHg in the stable group and 25.2±3.1 mmHg in the progressed group (P=0.006). Based on the pachymetry values for central corneal thickness, patients with thinner corneas more often progressed to glaucoma (P<0.0001). A multivariant regression analysis to determine risk factors for progression was positive primarily for higher peak IOPs, older age, male gender, argon laser trabeculoplasty, visual acuity 20/50, and no topical medical therapy or β-blocker therapy prior to the study.ConclusionsIOP reduction within the normal range over 5 years of follow-up reduces the chance of progression to primary open-angle glaucoma in OHT patients.Eye (2009) 23, 73–78; doi:10.1038/sj.eye.6702995; published online 5 October 2007 [ABSTRACT FROM AUTHOR]

PurposeTo evaluate the 24-h intraocular pressure (IOP) control of brimonidine/timolol fixed combination (BTFC) versusthe unfixed combination of its individual components, each dosed twice daily, in patients with primary open-angle glaucoma or ocular hypertension.MethodsAn observer-masked, randomized, crossover, active-controlled, two-centre comparison. Following a 6-week medicine-free period, patients were randomized to BTFC or to the unfixed combination of brimonidine and timolol for 3 months. Patients then were crossed over to the opposite treatment for another 3 months. At the end of the medicine-free period, and each treatment period, patients underwent 24-h IOP measurements at 0600, 1000, 1400, 1800, 2200, and 0200 hours.ResultsTwenty-eight patients completed this study. Both BTFC and the unfixed components showed a significant IOP reduction from untreated baseline (P<0.0001), and were statistically equal when compared directly, for each individual time point and for the 24-h IOP curve (P>0.05). The mean 24-h IOP was 24.6±1.9 for baseline, 19.2±1.9 for BTFC, and 19.2±1.6 mmHg for the unfixed components (P=1.0). Four patients were discontinued due to side effects. The most common ocular adverse event was ocular hyperaemia (n=3 with BTFC and n=5 with the unfixed components, P=0.7) and systemic adverse events were rare.ConclusionThis study suggests that both BTFC and the unfixed components of brimonidine and timolol provide a significant 24-h IOP reduction from untreated baseline, and statistically equal control when compared directly, at each time point and for the 24-h pressure curve.Eye (2008) 22, 1391–1397; doi:10.1038/sj.eye.6702906; published online 15 June 2007 [ABSTRACT FROM AUTHOR]

PurposeTo determine the predictive value of early Phase trials (I–II) for the ocular hypotensive efficacy observed in Phases III and IV.DesignA review of published literature.MethodsThis study evaluated 12 medicines in 65 articles in the literature with at least two phases available.ResultsFor medicines with Phase I results available (n=3), the average reduction in intraocular pressure (IOP) from untreated baseline was 16%, 26% for Phase II, 26% for Phase III, and 24% for Phase IV. For medicines with Phase II results available (n=6), the average reduction in IOP was 23%, 24% for Phase III, and 23% for Phase IV. For medicines with Phase III results available (n=11), the average reduction in IOP was 25% and 24% for Phase IV.ConclusionThis study indicates that early phase trials usually approximated the results of later regulatory studies and post-commercialization trials.Eye (2008) 22, 985–988; doi:10.1038/sj.eye.6702913; published online 22 June 2007 [ABSTRACT FROM AUTHOR]

PurposeTo provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure (TSS-IOP) quality-of-life survey that analyses specific issues related to side effects, patient satisfaction, and compliance.MethodsA prospective, observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey.ResultsFactors that correlated with patient satisfaction included perceived effectiveness of the medicine (F=7.47, P<0.001), ocular irritation (F=6.06, P<0.001), conjunctival hyperaemia (F=4.40, P<0.001), ease of use (F=8.52, P<0.001), and convenience of use (F=6.90, P<0.001). Patient compliance, acceptance of their illness, and knowledge of glaucoma were also related to perceived effectiveness of the medicine (P<0.001), ease of use (P<0.05) and convenience (P<0.001). Physician ratings of patient pressure control, side effects, and instillation problems also were significantly correlated to patient satisfaction (R=0.13–0.26, P=0.05–0.001). The physician ratings of patient compliance, however, were not significantly related to any dimension of patient satisfaction (P>0.05). Among monotherapy prostaglandin treatments, latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia (P<0.05) and eye irritation (P<0.01).ConclusionsThis study provides initial evidence that patient satisfaction may be related to compliance, perceived effectiveness of treatment, adverse side effects, ease and convenience of use, acceptance of illness, and knowledge of glaucoma.Eye (2006) 20, 583–590. doi:10.1038/sj.eye.6701932; published online 3 June 2005 [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15%, both added to timolol maleate 0.5% each given twice daily.Methods: In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6-week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period.Results: In all, 33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3+/-2.4 and the diurnal curve IOP was 22.0+/-1.3 mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6+/-3.3 and the diurnal curve IOP was 19.8+/-2.1 mmHg, while the timolol and unoprostone treatment showed a trough IOP of 20.9+/-3.8 and a diurnal curve IOP of 19.3+/-2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve, or in the reduction from baseline (P>0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800 h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P<0.0001) with unoprostone by survey.Conclusion: Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve. [ABSTRACT FROM AUTHOR]

PURPOSE:The diurnal efficacy and safety of the fixed combinations of latanoprost/timolol given once daily vs dorzolamide/timolol given twice daily in primary open-angle glaucoma or ocular hypertensive patients. DESIGN:A double-masked, two-centre, crossover comparison. RESULTS:In 33 patients, the mean diurnal IOP (0800-2000, measured every 2?h) for latanoprost/timolol fixed combination was 17.3±2.2?mmHg and for dorzolamide/timolol, the fixed combination was 17.0±2.0?mmHg (P=0.36). Additionally, there was no statistical difference for individual time points following a Bonferroni correction. A bitter taste was found more frequently with the dorzolamide/timolol fixed combination (n=6) than the latanoprost/timolol fixed combination (n=0) (P=0.040), while the latanoprost/timolol fixed combination demonstrated more conjunctival hyperaemia (n=9) than the dorzolamide/timolol fixed combination (n=2) (P=0.045). One patient was discontinued early from the dorzolamide/timolol fixed combination due to elevated IOP. CONCLUSION:This study suggests that the daytime diurnal IOP is not statistically different between the dorzolamide/timolol fixed combination and latanoprost/timolol fixed combination in primary open-angle glaucoma and ocular hypertensive patients.Eye (2004) 18, 1264-1269. doi:10.1038/sj.eye.6701446 Published online 25 June 2004 [ABSTRACT FROM AUTHOR]

AIMS:To evaluate the efficacy and safety of latanoprost/timolol maleate fixed combination (LTFC) given once daily vs the concomitant therapy of brimonidine twice daily and latanoprost once daily in primary open-angle glaucoma or ocular hypertensive subjects. METHODS:A prospective, double-masked, active-controlled comparison in which qualified subjects had all glaucoma medicines discontinued for 1 month and then were randomized to either LTFC or brimonidine and latanoprost concomitant therapy for 6 weeks. They were then switched to the other treatment regimen. The intraocular pressure (IOP) was measured at 0800, 1200, and 1600?h at baseline and at the end of Periods 1 and Period 2. RESULTS:In 32 subjects, the diurnal curve of the untreated IOP of 26.0±3.4 decreased to 17.8±2.5 on LTFC and 17.2±2.8?mmHg on brimonidine and latanoprost (P=0.31). At 0800 and 1600 h, the IOPs were statistically similar between the groups (P>0.05). At 1200?h the latanoprost and brimonidine treatment IOP was statistically lower (16.2±3.2) than LTFC (18.0±2.8?mmHg). However, the reduced IOP from untreated baseline was not statistically different at each time point and for the diurnal curve for each therapy (P<0.05). Safety was similar between groups for both solicited and unsolicited side effects (P>0.05). CONCLUSION:This study suggests that LTFC and concomitant therapy of brimonidine and latanoprost provide statistically similar diurnal IOP reduction from an untreated baseline.Eye (2004) 18, 990-995. doi:10.1038/sj.eye.6701375 Published online 19 March 2004 [ABSTRACT FROM AUTHOR]

Purpose To compare ocular tolerability of dorzolamide 2%, brinzolamide 1%, and placebo given three times daily. Methods A prospective, double-masked, three-centre, crossover comparison in which 25 ocular hypertensive or primary-open angle glaucoma subjects were randomized to receive dorzolamide, brinzolamide, or placebo three times daily for 3 days. Intraocular pressure, visual acuity, a visual analogue scale, and ocular and systemic symptom queries were completed at the end of each period. Results After chronic dosing, there was a significant difference in ocular pain on the visual analogue scale among the groups at the 10-s postinstillation time point with dorzolamide having the highest level (22.5±28.9) compared to brinzolamide (5.0±8.7) or placebo (3.2±10.4) (P = 0.0006). No differences between groups were observed preinstillation nor following dosing at 3 or 10-min postinstillation. On the initial instillation, the 10-s postinstillation pain was rated as 43.3±77.1, which was significantly higher than after chronic dosing (P = 0.017). On the ocular symptom query, dorzolamide had the highest incidence of burning/stinging and redness compared to the other groups, but was generally characterized as mild. There were no significant differences in the visual acuity at any time point. Conclusions This study suggests that subjects treated with dorzolamide suffer more ocular pain upon instillation compared to brinzolamide or placebo. However, pain symptoms are fewer following chronic dosing and are generally characterized as mild. [ABSTRACT FROM AUTHOR]

Aims To compare the diurnal intraocular pressure (IOP) efficacy and safety of timolol vs latanoprost in subjects with exfoliation glaucoma (XFG). Methods A 3-month prospective, single- masked, active-controlled, parallel comparison performed in six centres in Greece that randomized subjects in a 1:1 ratio to either latanoprost in the evening (2000 hours) and placebo in the morning (0800 hours), or timolol twice daily (0800 and 2000 hours). Results In all, 103 subjects completed the study. After 3 months of chronic dosing, the latanoprost group exhibited a trend to a greater diurnal IOP reduction from an untreated baseline (24.9±3.2–17.4±2.9) compared with timolol (24.7±2.8–18.3±1.9 mmHg) (P=0.07). Latanoprost showed a significantly greater IOP reduction at 0800 hours (-8.5 vs -6.0 mm Hg for timolol, P<0.0001) whereas no difference was observed between the two medications at 1000, 1400, and 2000 hours after a Bonferroni Correction. In addition, latanoprost demonstrated a narrower range of diurnal IOP (2.4) than timolol (3.2 mmHg)(P=0.0017). Safety was similar between groups, except there was more conjunctival hyperaemia with latanoprost (n=8) than timolol (n = 1)(P=0.01). Conclusions This study suggests that latanoprost provides a statistically lower 08:00-hour IOP and better range of IOP than timolol in the treatment of XFG glaucoma. Eye (2004) 18, 893–899. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the safety and efficacy of the timolol/dorzolamide fixed combination vs latanoprost 0.005% in exfoliation glaucoma patients. Methods We randomized in an observer-masked fashion 65 newly diagnosed exfoliation glaucoma patients to either the timolol/dorzolamide twice daily or latanoprost daily treatment for 2 months and then crossed these over to the other treatment. Results A total of fifty-four patients completed the study. After 2 months of chronic dosing, the morning intraocular pressure (IOP) (10:00) was reduced from a baseline of 31.2 ± 6.5 mmHg to 18.1 ± 3.0 with the fixed combination and to 18.9 ± 4.1 mmHg with latanoprost (P = 0.21). Six patients were discontinued early from both treatment periods owing to inadequate IOP control and two others were discontinued from latanoprost treatment only. The fixed combination showed a significantly greater incidence of taste perversion (P < 0.001) and stinging upon instillation (P = 0.036), while latanoprost showed a trend for increased conjunctival injection (P = 0.056). However, five patients demonstrated either bradycardia or asthmatic symptoms with initiation of the fixed combination therapy. One patient on latanoprost complained of dizziness. Patient preference was generally given to latanoprost (63 vs 20.3%) mainly because of its once daily dosing (P < 0001). Conclusions This study suggests that both latanoprost and the timolol/dorzolamide fixed combination are efficacious in the treatment of newly diagnosed exfoliation glaucoma. [ABSTRACT FROM AUTHOR]

A response by W. C. Stewart and colleagues to a letter to the editor about their article "Untreated 24-h intraocular pressures measured with Goldmann applanation tonometry vs nighttime supine pressures with Perkins applanation tonometry" in the 2010 issue is presented.

Presents a response by W.C. Stewart to a letter to the editor commenting on the article "Diurnal Intraocular Pressure Reduction With Latanoprost 0.005% Compared to Timolol Maleate 0.5% as Monotherapy in Subjects with Exfoliation Glaucoma," published in the February 27, 2004 issue of the journal "Eye."

A response by W. C. Stewart, J. A. Stewart, and M. Mychaskiw to the letter to the editor on the article "Cost effectiveness of latanoprost and timolol maleate for the treatment of glaucoma in Scandinavia and the United Kingdom using a decision-analytic health economic model" in the previous issue is presented.