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
Condition Keyword(s):
Intervention(s):
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
- Time Frame: 3 months
Secondary Measures
- Corneal fluorescein staining
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.