Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

• Status: Completed
• Trial end date: 2014-06-23
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Collaborator: ORA, Inc.
• Treatments: Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;

• Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

• Have any ocular/systemic health problems

• Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.