Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular...

Date First Received: March 7, 2006

Last Updated: September 25, 2007

Verified by: Allergan, August 2007

Clinical Trial Phase: Phase 2/Phase 3 | Start Date: 

Overall Status: Completed

Estimated Enrollment: 550

Brief Summary

Condition Keyword(s):

Intervention(s):

The purpose of this study is to assess the safety and efficacy of bimatoprost 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

Outcome Measures for this Clinical Trial

Primary Measures

  • Lowering intraocular pressure (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
  • Ocular seasonal allergies within the past 2 years

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 August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300443

Study ID Number: 192024-031

ClinicalTrials.gov Identifier: NCT00300443

Health Authority: United States: Food and Drug Administration

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