This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin...
Date First Received: October 2, 2007
Last Updated: May 5, 2008
Verified by: Allergan, May 2008
Clinical Trial Phase: Phase 4 | Start Date: September 2007
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Condition Keyword(s):
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: Bimatoprost 0.03%
- bimatoprost 0.03%, 1 drop nightly for 3 months
- Drug: travaprost 0.004%
- travaprost 0.004% eye drops, 1 drop nightly for 3 months
- Drug: latanoprost 0.005% eye drops
- latanoprost 0.005%, 1 drop nightly for 3 months
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
- Active Comparator: 3
Outcome Measures for this Clinical Trial
Primary Measures
- Hyperemia
- Time Frame: Month 3
Safety Issue?: No
- Time Frame: Month 3
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
Exclusion Criteria:
- Known contraindication to latanoprost, bimatoprost or travoprost
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension
- Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
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: Allergan
Overall Clinical Trial Officials and Contacts
Medical Director Study Director Allergan
Overall Contact: Allergan Inc clinicaltrials@allergan.com
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00539526
Study ID Number: MA-LUM-07-003
ClinicalTrials.gov Identifier: NCT00539526
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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