The purpose of this study is to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN and to vehicle in patients with open-angle glaucoma or ocular hypertension...
Date First Received: April 29, 2008
Last Updated: October 23, 2008
Verified by: Alcon Research, October 2008
Clinical Trial Phase: Phase 2 | Start Date: April 2008
Overall Status: Completed
Estimated Enrollment: 150
Brief Summary
Condition Keyword(s):
Intervention(s):
The purpose of this study is to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN and to vehicle in patients with open-angle glaucoma or ocular hypertension.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment
Study Primary Completion Date: September 2008
Intervention(s) in this Clinical Trial
- Drug: Travoprost
- Ophthalmic Solution
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Travoprost New Formulations
- Active Comparator: 2
- Travatan
- Placebo Comparator: 3
- Vehicle
Outcome Measures for this Clinical Trial
Primary Measures
- Mean IOP
- Time Frame: from baseline
Safety Issue?: Yes
- Time Frame: from baseline
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Open-angle glaucoma
- Ocular hypertension
Exclusion Criteria:
- VA worse than 0.60
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 Sponsor Information
Lead Sponsor: Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670033
Study ID Number: C-07-46
ClinicalTrials.gov Identifier: NCT00670033
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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