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

This study has been completed.

First Received on May 30, 2006. Last Updated on May 27, 2011 History of Changes

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

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:

Enrollment:	586
Study Start Date:	December 1999
Study Completion Date:	November 2001
Primary Completion Date:	November 2001 (Final data collection date for primary outcome measure)

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

Responsible Party:	Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier:	NCT00332436 History of Changes
Other Study ID Numbers:	190342-013T
Study First Received:	May 30, 2006
Last Updated:	May 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Brimonidine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on February 09, 2012