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

NCT02039765 | Completed Phase 1

• 1 other identifier: 863/13-100-0007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Ocular Redness

Outcome Measures

Primary Outcomes (4)

• Plasma Levels

  Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.

  Day 1 (Visit 2)

• Plasma Levels

  Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.

  Day 2 (Visit 3)

• Plasma Levels

  Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.

  Day 7 (Visit 4)

• Plasma Levels

  Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.

  Day 8 (Visit 5)

Secondary Outcomes (14)

• Visual Acuity

  Baseline (Visit 1)

• Slit Lamp Biomicroscopy

  Baseline (Visit 1)

• Intraocular Pressure

  Day 8 (Visit 5)

• Hematology and Blood Chemistry Analysis

  Baseline (Visit 1)

• Urinalysis

  Baseline (Visit 1)

Study Arms (1)

Brimonidine tartrate

EXPERIMENTAL

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).

Drug: Brimonidine tartrate

Interventions

Brimonidine tartrate DRUG

Brimonidine tartrate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead
• ORA, Inc.: collaborator

Study Sites (1)

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Hyperemia

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph Ciolino, MD

  ORA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 20, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 28, 2017

Record last verified: 2017-04

Locations

US (1)