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

Phase 1

Completed

• Conditions: Hyperemia
• Interventions: Drug: Brimonidine tartrate

• Registration Number: NCT02039765
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-20
• Study Start: 2014-02
• Primary Completion: 2014-03
• Study Completion: 2014-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brimonidine tartrate	Brimonidine tartrate	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).

Primary Outcome Measures

Name	Time	Method
Plasma Levels	Day 8 (Visit 5)	Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	Day 8 (Visit 5)	Visual acuity testing should be done with best correction at 10ft
Hematology and Blood Chemistry Analysis	Day 8 (Visit 5)	Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)
Urinalysis	Day 8 (Visit 5)	Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Slit Lamp Biomicroscopy	Day 8 (Visit 5)	Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia.
Intraocular Pressure	Baseline (Visit 1)	Intraocular Pressure measured at baseline (Visit 1)

Trial Locations

Locations (1)

Bausch & Lomb, Incorporated; 🇺🇸 Rochester, New York, United States