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The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
Details
| Lead sponsor | Alcon, a Novartis Company |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 218 |
| Start date | 2014-12 |
| Completion | 2015-12 |
Conditions
- Open-Angle Glaucoma
- Ocular Hypertension
Interventions
- Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension
- Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution
- Subject's habitual PGA monotherapy
Primary outcomes
- Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM — Baseline (Day 0), Week 4, Week 8 at 11 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
Countries
Japan