Overview

This trial is active, not recruiting.

Condition hyperemia
Treatment brimonidine tartrate
Phase phase 1
Sponsor Bausch & Lomb Incorporated
Collaborator ORA, Inc.
Start date February 2014
End date March 2014
Trial size 12 participants
Trial identifier NCT02039765, 863/13-100-0007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
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).
brimonidine tartrate

Primary Outcomes

Measure
Plasma Levels
time frame: Day 1 (Visit 2)
Plasma Levels
time frame: Day 2 (Visit 3)
Plasma Levels
time frame: Day 7 (Visit 4)
Plasma Levels
time frame: Day 8 (Visit 5)

Secondary Outcomes

Measure
Visual Acuity
time frame: Baseline (Visit 1)
Slit Lamp Biomicroscopy
time frame: Baseline (Visit 1)
Intraocular Pressure
time frame: Day 8 (Visit 5)
Hematology and Blood Chemistry Analysis
time frame: Baseline (Visit 1)
Urinalysis
time frame: Baseline (Visit 1)
Visual Acuity
time frame: Day 1 (Visit 2)
Visual Acuity
time frame: Day 7 (Visit 4)
Visual Acuity
time frame: Day 8 (Visit 5)
Slit Lamp Biomicroscopy
time frame: Day 1 (Visit 2)
Slit Lamp Biomicroscopy
time frame: Day 7 (Visit 4)
Slit Lamp Biomicroscopy
time frame: Day 8 (Visit 5)
Intraocular Pressure
time frame: Baseline (Visit 1)
Hematology and Blood Chemistry Analysis
time frame: Day 8 (Visit 5)
Urinalysis
time frame: Day 8 (Visit 5)

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Bausch & Lomb Incorporated.