The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular...
Date First Received: October 5, 2007
Last Updated: June 19, 2008
Verified by: Allergan, June 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2007
Overall Status: Active, not recruiting
Estimated Enrollment: 587
Brief Summary
Condition Keyword(s):
Intervention(s):
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: August 2008
Intervention(s) in this Clinical Trial
- Drug: bimatoprost 0.03% eye drops
- Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
- Drug: latanoprost 0.005% eye drops
- Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- IOP
- Time Frame: Week 18
Safety Issue?: No
- Time Frame: Week 18
Secondary Measures
- Adverse Events
- Time Frame: Day 1 - Week 18
Safety Issue?: No
- Time Frame: Day 1 - Week 18
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Ocular hypertension or chronic glaucoma
- Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
- Uncontrolled medical conditions
- Hypersensitivity to study medications
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
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541242
Study ID Number: 192024-034
ClinicalTrials.gov Identifier: NCT00541242
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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