A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.

First Received: May 28, 2003 Last Updated: August 4, 2008 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00061529

Purpose

The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: Brimonidine Tartrate Ophthalmic Solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Alcon Research:

Study Start Date:	January 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients of any race
two (2) years of age or older
of either sex
diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)or ocular hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061529

Locations

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Study ID Numbers:	C-02-49
Study First Received:	May 28, 2003
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00061529 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Open-Angle Glaucoma
Ocular Hypertension

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Adrenergic Agonists
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Brimonidine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Adrenergic Agonists
Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle
Cardiovascular Diseases
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on July 02, 2009