Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0...

Date First Received: February 22, 2007

Last Updated: December 26, 2007

Verified by: Allergan, December 2007

Clinical Trial Phase: Phase 4 | Start Date: August 2006

Overall Status: Completed

Estimated Enrollment: 266

Brief Summary

Condition Keyword(s):

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

  • Drug: bimatoprost 0.03% eye drops
    • bimatoprost 0.03% 1 drop nightly for 3 months
  • Drug: travaprost 0.004% eye drops
    • travaprost 0.004% 1 drop nightly for 3 months

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • IOP
    • Time Frame: Month 3
      Safety Issue?: No

Secondary Measures

  • Tolerability
    • Time Frame: Month 3
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% daily and in need of additional
  • IOP-lowering
  • Best-corrected visual acuity of 20/100 or better in each eye
  • Visual filed within 6 months of study entry

Exclusion Criteria:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months

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 Affairs Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00440011

Study ID Number: MA-LUM01

ClinicalTrials.gov Identifier: NCT00440011

Health Authority: United States: Institutional Review Board

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