Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin...

Date First Received: October 2, 2007

Last Updated: May 5, 2008

Verified by: Allergan, May 2008

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

Overall Status: Recruiting

Estimated Enrollment: 150

Brief Summary

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

Study Type: Interventional

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

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

  • Drug: Bimatoprost 0.03%
    • bimatoprost 0.03%, 1 drop nightly for 3 months
  • Drug: travaprost 0.004%
    • travaprost 0.004% eye drops, 1 drop nightly for 3 months
  • Drug: latanoprost 0.005% eye drops
    • latanoprost 0.005%, 1 drop nightly for 3 months

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Active Comparator: 2
  • Active Comparator: 3

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

  • Known contraindication to latanoprost, bimatoprost or travoprost
  • Uncontrolled systemic disease
  • Active ocular disease other than glaucoma or ocular hypertension
  • Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control

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  

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00539526

Study ID Number: MA-LUM-07-003

ClinicalTrials.gov Identifier: NCT00539526

Health Authority: United States: Institutional Review Board

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