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Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
Details
| Lead sponsor | Alcon Research |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1184 |
| Start date | 2011-05 |
| Completion | 2013-01 |
Conditions
- Open-Angle Glaucoma
- Ocular Hypertension
Interventions
- Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension
- Vehicle
- Brinzolamide 1% ophthalmic suspension
- Brimonidine tartrate 0.2% ophthalmic solution
Primary outcomes
- Mean Diurnal IOP Change From Baseline at Month 3 — Baseline (Day 1), Month 3
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).