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

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ClinicalTrials.gov Identifier: NCT00332384
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : May 30, 2011
Information provided by:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2000
Primary Completion Date : November 2001
Study Completion Date : November 2001

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. IOP

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

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 conditions
  • contraindication to beta-adrenoceptor antagonist or brimonidine therapy

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): NCT00332384

United States, California
Newport Beach, California, United States
Sponsors and Collaborators

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00332384     History of Changes
Other Study ID Numbers: 190342-012T
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists