Conditions: Open-Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.

Detailed description:

Arms:
arm 1: Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. arm 2: Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. arm 3: Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.

Interventions: intervention 1: Fixed Combination intervention 2: Bimatoprost intervention 3: Timolol intervention 4: Placebo Segment intervention 5: Timolol 0.5%
Intervention descriptions: intervention 1: Continuous elution from the ocular insert. intervention 2: Continuous elution from the ocular insert. This is an active control arm. intervention 3: Continuous elution from the ocular insert. This is an active control arm. intervention 4: One segment of placebo (no drug product) intervention 5: 0.5% timolol drops twice daily.

Protocol document: