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

This study has been completed.

First Received: May 30, 2006 No Changes Posted

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00332059

Purpose

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

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Bimatoprost

U.S. FDA Resources

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

Further study details as provided by Allergan:

Primary Outcome Measures:

Estimated Enrollment:	440
Study Start Date:	May 2003
Estimated Study Completion Date:	September 2004

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Uncontrolled medical conditions
Contraindication to beta-adrenoceptor antagonist therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332059

Locations

United States, Maryland

Bel Air, Maryland, United States
Austria

Vienna, Austria
Canada, Quebec

Montreal, Quebec, Canada
Germany

Berlin, Germany

Sponsors and Collaborators

Allergan

More Information

No publications provided

Study ID Numbers:	192024-026T
Study First Received:	May 30, 2006
Last Updated:	May 30, 2006
ClinicalTrials.gov Identifier:	NCT00332059 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Bimatoprost
Adrenergic Agents
Eye Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Glaucoma
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on May 06, 2009