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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00332540
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 Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension


Condition Intervention Phase
Ocular Hypertension
Drug: bimatoprost/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: 520
Study Start Date: August 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (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 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: NCT00332540

Locations
United States, New York
Rochester, New York, United States
Canada, Quebec
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00332540     History of Changes
Other Study ID Numbers: 192024-018T
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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Timolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014