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

Phase 1CompletedNCT02039765

Bausch & Lomb Incorporated12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Hyperemia

Interventions

Brimonidine tartrateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bausch & Lomb, Incorporated

Rochester, New York, United States

Outcomes

Primary Outcomes

Plasma Levels

Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.

Time frame: Day 1 (Visit 2)

Plasma Levels

Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.

Time frame: Day 2 (Visit 3)

Plasma Levels

Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.

Time frame: Day 7 (Visit 4)

Plasma Levels

Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.

Time frame: Day 8 (Visit 5)

Secondary Outcomes

Visual Acuity

Visual acuity testing should be done with best correction at 10ft

Time frame: Baseline (Visit 1)

Slit Lamp Biomicroscopy

Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.

Time frame: Baseline (Visit 1)

Intraocular Pressure

Intraocular Pressure measured at baseline Day 8 (Visit 5)

Time frame: Day 8 (Visit 5)

Hematology and Blood Chemistry Analysis

Data from ClinicalTrials.gov

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