A Single Dose Comfort Comparison of Travoprost Bak Free 0.004% (TRAZATAN Z) in One Eye Versus Latanoprost 0.005% (XALATAN) in the Opposite Eye in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

Verified by: Alcon Research, February 2010
First Received: September 10, 2007 | Last Updated: February 23, 2010 | Phase: Phase 4 | Start Date: May 2007
Overall Status: Completed | Estimated Enrollment: 54
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This study is a single dose comfort comparison of Travoprost Bak Free 0.004% (TRAVATAN Z) in one eye versus Latanoprost 0.005% (XALATAN) in the opposite eye in patients with Primary Open-Angle Glaucoma or Ocular...

Brief Summary

Official Title: “A Single Dose Comfort Comparison of Travoprost Bak Free 0.004% in One Eye Versus Latanoprost 0.005% in the Opposite Eye in Patients With Primary Open-angle Glaucoma or Ocular Hypertension”

This study is a single dose comfort comparison of Travoprost Bak Free 0.004% (TRAVATAN Z) in one eye versus Latanoprost 0.005% (XALATAN) in the opposite eye in patients with Primary Open-Angle Glaucoma or Ocular Hypertension

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

  • Drug: TRAVATAN Z
    • 1 drop TRAVATAN Z in one eye once time
  • Drug: XALATAN
    • one drop XALATAN in other eye one time

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: TRAVATAN Z
    • 1 drop TRAVATAN Z in one eye once time
  • Active Comparator: XALATAN
    • one drop XALATAN in other eye one time

Outcome Measures for this Clinical Trial

Primary Measures

  • The Product Comfort Preference Scale Immediately After Dosing.
    • Time Frame: 5 seconds
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Have a clinical diagnosis of ocular hypertension, primary open-angel, exfoliation or pigment dispersion glaucoma in both eyes; visual acuity should be 20/100 or better in both eyes.

Exclusion Criteria:

  • Age related

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: Alcon Research Industry

Overall Clinical Trial Officials and Contacts

Mark Jasek, PhD Study Director Alcon Research  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00527592

Study ID Number: SMA-07-01

ClinicalTrials.gov Identifier: NCT00527592

Health Authority: United States: Institutional Review Board

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