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A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 137 |
| Start date | 2012-01 |
| Completion | 2012-10 |
Conditions
- Glaucoma
- Ocular Hypertension
Interventions
- 0.1% brimonidine tartrate ophthalmic solution
- 0.01% bimatoprost ophthalmic solution
- 0.2% hypromellose lubricant eye drops
- latanoprost 0.005% ophthalmic solution
Primary outcomes
- Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) — Baseline, Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.
Countries
United States