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

The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular...

Date First Received: May 30, 2006

Last Updated: May 30, 2006

Verified by: Allergan, May 2006

Clinical Trial Phase: Phase 3 | Start Date: May 2003

Overall Status: Completed

Estimated Enrollment: 440

Brief Summary

Condition Keyword(s):

The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: bimatoprost/timolol fixed combination

Outcome Measures for this Clinical Trial

Primary Measures

  • IOP

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Clinical diagnosis of glaucoma or ocular hypertension in both eyes
  • Patient requires IOP-lowering drug in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Contraindication to beta-adrenoceptor antagonist therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Allergan

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332059

Study ID Number: 192024-026T

ClinicalTrials.gov Identifier: NCT00332059

Health Authority: United States: Food and Drug Administration

Clinical Trials Authorship and Review

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