Clinical trial NCT02039765: Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperemia
Keywords: Ocular Redness
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma Levels
timeFrame: Day 1 (Visit 2)
measure: Plasma Levels
timeFrame: Day 2 (Visit 3)
measure: Plasma Levels
timeFrame: Day 7 (Visit 4)
measure: Plasma Levels
timeFrame: Day 8 (Visit 5)
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline (Visit 1)
measure: Slit Lamp Biomicroscopy
timeFrame: Baseline (Visit 1)
measure: Intraocular Pressure
timeFrame: Day 8 (Visit 5)
measure: Hematology and Blood Chemistry Analysis
timeFrame: Baseline (Visit 1)
measure: Urinalysis
timeFrame: Baseline (Visit 1)
measure: Visual Acuity
timeFrame: Day 1 (Visit 2)
measure: Visual Acuity
timeFrame: Day 7 (Visit 4)
measure: Visual Acuity
timeFrame: Day 8 (Visit 5)
measure: Slit Lamp Biomicroscopy
timeFrame: Day 1 (Visit 2)
measure: Slit Lamp Biomicroscopy
timeFrame: Day 7 (Visit 4)
measure: Slit Lamp Biomicroscopy
timeFrame: Day 8 (Visit 5)
measure: Intraocular Pressure
timeFrame: Baseline (Visit 1)
measure: Hematology and Blood Chemistry Analysis
timeFrame: Day 8 (Visit 5)
measure: Urinalysis
timeFrame: Day 8 (Visit 5)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
affiliation: ORA, Inc.
name: Joseph Ciolino, MD
role: STUDY_DIRECTOR
References: