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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperemia

Intervention: Brimonidine tartrate (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Joseph Ciolino, MD, Study Director, Affiliation: ORA, Inc.

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Primary outcome:

Plasma Levels

Plasma Levels

Plasma Levels

Plasma Levels

Secondary outcome:

Visual Acuity

Slit Lamp Biomicroscopy

Intraocular Pressure

Hematology and Blood Chemistry Analysis

Urinalysis

Visual Acuity

Visual Acuity

Visual Acuity

Slit Lamp Biomicroscopy

Slit Lamp Biomicroscopy

Slit Lamp Biomicroscopy

Intraocular Pressure

Hematology and Blood Chemistry Analysis

Urinalysis

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Bausch & Lomb, Incorporated, Rochester, New York 14609, United States
Additional Information

Starting date: February 2014
Last updated: March 28, 2014

Page last updated: August 20, 2015

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