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

NCT ID: NCT02039765

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-04-30

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.

Conditions

Hyperemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Brimonidine tartrate

Intervention Type: DRUG

Interventions

Brimonidine tartrate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Ciolino, MD

Role: STUDY_DIRECTOR

ORA, Inc.

Locations

Bausch & Lomb, Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

863/13-100-0007

Identifier Type: -

Identifier Source: org_study_id