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

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Hyperemia

Treatments: Drug: Brimonidine tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02039765

863/13-100-0007

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Brimonidine tartrate

Experimental group

Description:

One drop of brimonidine tartrate ophthalmic solution 0.025% in each eye once at Visit 2 (Day 1) then four times daily (QID) approximately 4 hours apart at Visit 3 (Day 2) through day 6, and then once at Visit 4 (Day 7).

Treatment:

Drug: Brimonidine tartrate