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 brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to 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: July 2006
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Condition Keyword(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 brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops
- latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
- Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops
- latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily 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% QD
- IOP greater than or equal to 18mm Hg on latanoprost 0.005%
- Best-corrected VA of 20/200 or better in each eye
- Visual field 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 October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00440141
Study ID Number: MA-AP01
ClinicalTrials.gov Identifier: NCT00440141
Health Authority: United States: Institutional Review Board
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