Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

First Received: May 30, 2006 No Changes Posted

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00332436

Purpose

The purpose of this study is to assess the safety and efficacy of Brimonidine/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Condition	Intervention	Phase
Ocular Hypertension	Drug: brimonidine/timolol fixed combination	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Estimated Enrollment:	560
Study Start Date:	January 2000
Estimated Study Completion Date:	November 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

Uncontrolled medical condition
Contraindication to beta-adrenoceptor antagonist or brimonidine therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332436

Locations

United States, Kentucky

Louisville, Kentucky, United States

Sponsors and Collaborators

Allergan

More Information

No publications provided

Study ID Numbers:	190342-013T
Study First Received:	May 30, 2006
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00332436 History of Changes
Health Authority:	United States: Food and Drug Administration

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
Adrenergic Agonists

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010