Conditions: Ocular Hypertension Primary Open-Angle Glaucoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 163
Healthy volunteers: no

Brief summary:
This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Detailed description:

Arms:
arm 1: AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 2: AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 3: AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 4: AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 5: AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 6: AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. arm 7: AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. arm 8: bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Interventions: intervention 1: AGN-210961 Formulation 1 intervention 2: AGN-210961 Formulation 2 intervention 3: AGN-210961 Formulation 3 intervention 4: AGN-210961 Formulation 4 intervention 5: AGN-210961 Formulation 5 intervention 6: AGN-210961 Formulation 6 intervention 7: AGN-210961 Formulation 7 intervention 8: bimatoprost ophthalmic solution 0.03%
Intervention descriptions: intervention 1: AGN-210961 Formulation 1 in one eye once daily for 7 days. intervention 2: AGN-210961 Formulation 2 in one eye once daily for 7 days. intervention 3: AGN-210961 Formulation 3 in one eye once daily for 7 days. intervention 4: AGN-210961 Formulation 4 in one eye once daily for 7 days. intervention 5: AGN-210961 Formulation 5 in one eye once daily for 7 days. intervention 6: AGN-210961 Formulation 6 in one eye once daily for 7 days. intervention 7: AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. intervention 8: bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Protocol document: