Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• have ocular health within normal limits.

• have blood (hematology, blood chemistry) and urine analysis within normal limits.

• have a body weight within 15% of ideal weight

Exclusion Criteria:

• have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;

• have any active systemic or ocular disorder other than refractive disorder.

• have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption.

• have a history of chronic alcohol consumption.

• consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study.

• have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to Visit 2;

• have significant weight change (over 10 pounds) within the 60 days prior to Visit 2;

• have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to Visit 2;

• have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg);

• have intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.