Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension

Abstract

BackgroundThe purpose of this study was to evaluate the safety and efficacy of a long-term, twice-daily brinzolamide 1%/timolol 0.5% fixed combination ophthalmic suspension (BRINZ/TIM-FC) in Japanese patients with open-angle glaucoma (primary open-angle, normal-tension, exfoliation, or pigmentary) or ocular hypertension.MethodsThis was a prospective, nonrandomized, multicenter, open-label, Phase III study of Japanese patients aged ≥20 years with diagnoses of open-angle glaucoma or ocular hypertension. Patients were treated with topical BRINZ/TIM-FC twice daily for 52 weeks. The primary endpoint was mean reduction from baseline in intraocular pressure. Data were analyzed using repeated-measures analysis of variance and t-tests. Adverse events and ophthalmic, physiologic, and laboratory parameters were measured throughout the study as safety endpoints. A total of 126 patients (mean ± SD age, 63±12 years) were enrolled, and 125 received BRINZ/TIM-FC.ResultsMean intraocular pressure was significantly reduced from baseline at weeks 4 through 52, with changes ranging from −4.1 mmHg to −5.7 mmHg (P<0.0001, all time points). Adverse events related to BRINZ/TIM-FC treatment were observed in 22% of patients. No substantial changes from baseline were observed in ophthalmic, physiologic, or laboratory variables.ConclusionLong-term, twice-daily BRINZ/TIM-FC therapy produced and maintained significant intraocular pressure reductions and was generally well tolerated in Japanese patients with open-angle glaucoma or ocular hypertension.

Safety and efficacy of switching from dorzolamide 1.0%/timolol maleate 0.5% eye drops to brinzolamide 1.0%/timolol maleate 0.5% eye drops

“… 10 Moreover, we observed no severe adverse reactions, which is in agreement with past reports. 4 – 6 , 9 – 11 , 13 , 14 Also in agreement with past reports, 10 , 13 , 14 less stinging was reported in the BTFC group than in the DTFC group. We believe that less stinging occurred because of pH differences between medications (dorzolamide/timolol pH =5.6, brinzolamide/timolol pH =7.2).…”

“…Several reports on the efficacy of BTFC eye drops in Japanese patients have been published. 4 – 6 Yoshikawa et al 4 treated 301 patients with primary open-angle glaucoma or ocular hypertension with timolol for 4 weeks. Patients were then divided into two groups, with one group switched to BTFC drops (150 cases) and the other group continuing on timolol drops (151 cases).…”

“…Adverse reactions observed in the BTFC group were punctate keratitis (1%), blurred vision (1%), ocular pruritus (1%), and dysgeusia (1%). Nakajima et al 6 administered BTFC eye drops to 126 patients with primary open-angle glaucoma or ocular hypertension for 52 weeks. After the 52-week treatment period, IOP had been reduced between 4.1 mmHg and 5.7 mmHg in each patient.…”

“…This brinzolamide/timolol fixed-combination (BTFC) eye drop was shown to be extremely effective in reducing IOP in Japanese glaucoma patients. 4 – 6 However, dorzolamide/timolol fixed-combination (DTFC) eye drops have been shown to be better for reducing IOP reduction than both latanoprost 7 and brimonidine/timolol fixed-combination drops. 8 It has been shown that switching patients from a DTFC eye drop to a BTFC eye drop is both safe and effective in reducing IOP, 9 – 11 but this has not been specifically examined in a Japanese population.…”