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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 55
Updated:4/29/2017
Start Date:February 2014
End Date:April 2014

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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.

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.


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.
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Rochester, New York 14609
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