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

Completed · Phase 3

Conditions studied: Hyperemia

In brief

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.

Key facts

Study ID

NCT01959243

Run by

Bausch & Lomb Incorporated

People needed

507

Starts

2014-02-22

Expected to finish

2014-06-23

Last updated by the study team

2019-10-23

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bausch Site 3 — Phoenix, Arizona, United States
• Bausch Site 4 — Havre de Grace, Maryland, United States
• Bausch Site 1 — Andover, Massachusetts, United States
• Bausch Site 2 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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