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

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular...

Date First Received: October 5, 2007

Last Updated: June 19, 2008

Verified by: Allergan, June 2008

Clinical Trial Phase: Phase 4 | Start Date: December 2007

Overall Status: Active, not recruiting

Estimated Enrollment: 587

Brief Summary

Condition Keyword(s):

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

  • Drug: bimatoprost 0.03% eye drops
    • Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
  • Drug: latanoprost 0.005% eye drops
    • Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • IOP
    • Time Frame: Week 18
      Safety Issue?: No

Secondary Measures

  • Adverse Events
    • Time Frame: Day 1 - Week 18
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Ocular hypertension or chronic glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • 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 Sponsor Information

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541242

Study ID Number: 192024-034

ClinicalTrials.gov Identifier: NCT00541242

Health Authority: United States: Institutional Review Board

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