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

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ClinicalTrials.gov Identifier: NCT00332072
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 the treatment of 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 : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2001
Primary Completion Date : August 2003
Study Completion Date : August 2003

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 ocular hypertension or chronic glaucoma in both eyes
  • Patient needs IOP-lowering drug in both eyes

Exclusion Criteria:

  • Uncontrolled medical condition
  • 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): NCT00332072


Locations
United States, Utah
Ogden, Utah, United States
Sponsors and Collaborators
Allergan
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00332072     History of Changes
Other Study ID Numbers: 192024-021T
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