Conditions: Primary Open-Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Primary Open-Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief summary:
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Detailed description:

Arms:
arm 1: Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months. arm 2: Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.

Interventions: intervention 1: Bimatoprost intervention 2: Timolol 0.5% intervention 3: Placebo Eye Drops intervention 4: Placebo Ocular Insert
Intervention descriptions: intervention 1: Bimatoprost ocular insert intervention 2: Timolol 0.5% solution intervention 3: Placebo topical eye drops intervention 4: Ocular insert without any active drug

Protocol document: