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 sus...

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Autores principales:	Nakajima M, Iwasaki N, Adachi M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/b3c0635aef9142408fbea9aa0ed85c86
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spelling	oai:doaj.org-article:b3c0635aef9142408fbea9aa0ed85c862021-12-02T06:50:13ZPhase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension1177-5483https://doaj.org/article/b3c0635aef9142408fbea9aa0ed85c862013-12-01T00:00:00Zhttp://www.dovepress.com/phase-iii-safety-and-efficacy-study-of-long-term-brinzolamidetimolol-f-a15388https://doaj.org/toc/1177-5483 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<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.Conclusion: Long-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.Keywords: clinical trial, intraocular pressure, long-term safety, JapanNakajima MIwasaki NAdachi MDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 149-156 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Nakajima M Iwasaki N Adachi M Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
description	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<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.Conclusion: Long-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.Keywords: clinical trial, intraocular pressure, long-term safety, Japan
format	article
author	Nakajima M Iwasaki N Adachi M
author_facet	Nakajima M Iwasaki N Adachi M
author_sort	Nakajima M
title	Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
title_short	Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
title_full	Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
title_fullStr	Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
title_full_unstemmed	Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension
title_sort	phase iii safety and efficacy study of long-term brinzolamide/timolol fixed combination in japanese patients with open-angle glaucoma or ocular hypertension
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/b3c0635aef9142408fbea9aa0ed85c86
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Phase III safety and efficacy study of long-term brinzolamide/timolol fixed combination in Japanese patients with open-angle glaucoma or ocular hypertension

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