Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution… (NCT02039765) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
United States12 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.