Conditions: Ocular Hypertension Glaucoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Detailed description:

Arms:
arm 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. arm 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. arm 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. arm 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. arm 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Interventions: intervention 1: AGN-210669 ophthalmic solution, 0.075% intervention 2: AGN-210669 ophthalmic solution, 0.05% intervention 3: AGN-210669 ophthalmic solution, 0.025% intervention 4: bimatoprost ophthalmic solution 0.03% intervention 5: AGN-210669 vehicle ophthalmic solution
Intervention descriptions: intervention 1: AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks. intervention 2: AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks. intervention 3: AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. intervention 4: Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks. intervention 5: AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Protocol document: