Back to Journals » Clinical Ophthalmology » Volume 8

Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension

Authors Nagayama M, Nakajima T, Ono J

Received 8 October 2013

Accepted for publication 18 November 2013

Published 13 January 2014 Volume 2014:8 Pages 219—228

DOI https://doi.org/10.2147/OPTH.S55590

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2


Mikio Nagayama1, Toru Nakajima2, Junji Ono3

1Nagayama Eye Clinic, Okayama, 2Nakajima Eye Clinic, Shizuoka, 3Ono Ophthalmic Clinic, Shizuoka, Japan

Background: The purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.
Methods: This randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.
Results: In total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges -2.5 to -3.4 mmHg and -2.7 to -3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to -0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was <1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.
Conclusion: Twice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated.

Keywords: Azarga®, open-angle glaucoma, intraocular pressure

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]