Conditions: Glaucoma, Open-Angle Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms:
arm 1: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. arm 2: AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 3: AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 4: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. arm 5: bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 6: bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

Interventions: intervention 1: AGN-210669 intervention 2: bimatoprost intervention 3: bimatoprost vehicle
Intervention descriptions: intervention 1: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2. intervention 2: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2. intervention 3: bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.

Protocol document: