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 on May 28, 2003. Last Updated on August 4, 2008 History of Changes

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

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

Keywords provided by Alcon Research:

Open-Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012