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• W2090450927 abstract "Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension Masayuki Nakajima,1 Naoki Iwasaki,2 Masaki Adachi31Nakajima Eye Clinic, Kyoto, 2Iwasaki Eye Clinic, 3Adachi Eye Clinic, Osaka, JapanBackground: The 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.Methods: This 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.Results: Mean intraocular pressure was significantly reduced from baseline at weeks 4 through 52, with changes ranging from –4.1 mmHg to –5.7 mmHg (P" @default.
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• W2090450927 date "2013-12-01" @default.
• W2090450927 modified "2023-09-25" @default.
• W2090450927 title "Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension" @default.
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• W2090450927 doi "https://doi.org/10.2147/opth.s55456" @default.
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