Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0...
Date First Received: February 22, 2007
Last Updated: December 26, 2007
Verified by: Allergan, December 2007
Clinical Trial Phase: Phase 4 | Start Date: August 2006
Overall Status: Completed
Estimated Enrollment: 266
Brief Summary
Condition Keyword(s):
Intervention(s):
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: October 2007
Intervention(s) in this Clinical Trial
- Drug: bimatoprost 0.03% eye drops
- bimatoprost 0.03% 1 drop nightly for 3 months
- Drug: travaprost 0.004% eye drops
- travaprost 0.004% 1 drop nightly for 3 months
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- IOP
- Time Frame: Month 3
Safety Issue?: No
- Time Frame: Month 3
Secondary Measures
- Tolerability
- Time Frame: Month 3
Safety Issue?: No
- Time Frame: Month 3
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Glaucoma or ocular hypertension in both eyes
- Currently being treated with latanoprost 0.005% daily and in need of additional
- IOP-lowering
- Best-corrected visual acuity of 20/100 or better in each eye
- Visual filed within 6 months of study entry
Exclusion Criteria:
- Secondary glaucoma
- Active intraocular inflammation or macular edema
- Intraocular surgery or laser surgery within the past 3 months
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 Affairs Study Director Allergan
Additional Information
Information obtained from ClinicalTrials.gov on August 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00440011
Study ID Number: MA-LUM01
ClinicalTrials.gov Identifier: NCT00440011
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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