Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Bimatoprost; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Ocular hypertension or primary open-angle glaucoma

• Females of non-childbearing potential

• Subject requires IOP-lowering therapy in both eyes

• IOP ≥ 22 mm Hg and ≤ 34 mm Hg

• Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

• Uncontrolled systemic disease

• Active ocular disease

• Alteration of existing chronic systemic medications

• Known allergy or sensitivity to the study medications

• Ophthalmic corticosteroids

• Visual field loss which in the opinion of the investigator is functionally significant

• History of ocular laser, intraocular surgery, or refractive surgery