Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
Completed · Phase 1
Conditions studied: Hyperemia
In brief
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.
Key facts
- Study ID
- NCT02039765
- Run by
- Bausch & Lomb Incorporated
- People needed
- 12
- Starts
- 2014-02-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2017-04-28
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Bausch & Lomb, Incorporated — Rochester, New York, United States
Full record on ClinicalTrials.gov
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