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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00332436
First received: May 30, 2006
Last updated: May 27, 2011
Last verified: May 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • IOP

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
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

ClinicalTrials.gov processed this record on April 21, 2017