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

Verified by: Allergan, September 2011
First Received: September 28, 2007 | Last Updated: September 19, 2011 | Phase: Phase 2 | Start Date: November 2007
Overall Status: Completed | Estimated Enrollment: 222
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A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular...

Brief Summary

A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

  • Drug: bimatoprost eye drops
    • 1 drop in each eye daily for 1 month
  • Drug: placebo
    • 1 drop in each eye daily for 1 month

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • bimatoprost eye drops
  • Placebo Comparator: 2
    • placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
    • Time Frame: Baseline, Month 1
      Safety Issue?: No

Secondary Measures

  • Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
    • Time Frame: Month 1
      Safety Issue?: No
  • Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
    • Time Frame: Baseline, Month 1
      Safety Issue?: No
  • Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
    • Time Frame: Month 1
      Safety Issue?: No
  • Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
    • Time Frame: Month 1
      Safety Issue?: No
  • Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
    • Time Frame: Month 1
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Chronic glaucoma or ocular hypertension
  • IOP controlled on Xalatan

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Known hypersensitivity to study medications

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 Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00538304

Study ID Number: 192024-035

ClinicalTrials.gov Identifier: NCT00538304

Health Authority: United States: Food and Drug Administration

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