Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

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

Details

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

Criteria

Inclusion Criteria:

• Ocular hypertension or primary open-angle glaucoma in each eye

• Requires IOP-lowering therapy in both eyes

• Visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

• Experienced significant weight change (over 10 pounds) within 60 days

• History of alcohol or drug addiction

• History of migraines or frequent headaches

• Anticipated wearing of contact lenses during the study

• Required chronic use of ocular medications during study

• Eye surgery within 6 months

• Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months

• Use of oral, intramuscular, intravenous corticosteroids within 21 days

• Use of ophthalmic corticosteroids within 2 months