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.

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

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

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

Lead Investigator: Alcon Research Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

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