Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension
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 w...
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| Formato: | article |
| Lenguaje: | EN |
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Dove Medical Press
2014
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| Acceso en línea: | https://doaj.org/article/81d6a1bcdb464d0b8dc93a5d6c140498 |
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| Sumario: | 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 |
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