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
Endpoint Classification: Safety/Efficacy Study
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
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 April 17, 2014