Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

The purpose of the study is to determine if TRAVATAN Z improves ocular surface health in patients with open-angle glaucoma or ocular hypertension...

Date First Received: September 25, 2008

Last Updated: November 6, 2008

Verified by: Alcon Research, November 2008

Clinical Trial Phase: Phase 3 | Start Date: October 2008

Overall Status: Recruiting

Estimated Enrollment: 1100

Brief Summary

The purpose of the study is to determine if TRAVATAN Z improves ocular surface health in patients with open-angle glaucoma or ocular hypertension.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

  • Drug: Travoprost 0.004%, BAC-Free
    • Ophthalmic solution
  • Drug: Latanoprost 0.005%
    • Ophthalmic solution

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Travatan Z
  • Active Comparator: 2
    • Xalatan

Outcome Measures for this Clinical Trial

Primary Measures

  • Ocular Surface Disease Index Questionnaire
    • Time Frame: 3 months
      Safety Issue?: No

Secondary Measures

  • Corneal fluorescein staining
    • Time Frame: 3 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Must have ocular surface symptoms and corneal staining.
  • Must have a clinical diagnosis of open-angle glaucoma, or ocular hypertension in at least one eye.
  • Must have been on Xalatan as a mono-therapy for at least 1 month.
  • Must have healthy eyes, stable open-angle glaucoma or ocular hypertension, and if on systemic medications, must be on stable doses of those medications.

Exclusion Criteria:

  • No history of significant dry eye or KCS.
  • No contact lens wear within 30 days of the study and no contact lens wear during the study.
  • No corticosteroid use by any route within 30 days of the study and no use during the study

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?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Alcon Research

Overall Clinical Trial Officials and Contacts

Overall Contact: Alcon Call Center 1-888-451-3937 

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00761319

Study ID Number: C-08-47

ClinicalTrials.gov Identifier: NCT00761319

Health Authority: United States: Food and Drug Administration

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