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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00332059
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Ocular Hypertension Drug: bimatoprost/timolol fixed combination Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2003
Primary Completion Date : September 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. IOP

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00332059     History of Changes
Other Study ID Numbers: 192024-026T
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents