Official Title: “Phase III of TRAVATAN Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension”

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), Single Group Assignment

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Travatan 0.004%, BAC Free
  • Solution

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Travatan Z
• Active Comparator: 2
  • Xalatan Ophthalmic Solution

Primary Measures

• Ocular Surface Disease index questionnaire at 3 months
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

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

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

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?: Accepts Healthy Volunteers

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00690794

Study ID Number: C-08-03

ClinicalTrials.gov Identifier: NCT00690794

Health Authority: United States: Food and Drug Administration