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A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy
This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 126 |
| Start date | 2010-11 |
| Completion | 2012-08 |
Conditions
- Glaucoma
- Ocular Hypertension
Interventions
- bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution
Primary outcomes
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye — Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Countries
India