This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular...
Date First Received: April 6, 2007
Last Updated: May 5, 2008
Verified by: Allergan, May 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2006
Overall Status: Recruiting
Estimated Enrollment: 15
Brief Summary
Condition Keyword(s):
Intervention(s):
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Drug: brimonidine 0.1% (Alphagan® P)
- Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- mean IOP for 24-hour period at 4 weeks
- Time Frame: 1 Month
Safety Issue?: No
- Time Frame: 1 Month
Secondary Measures
- ocular perfusion pressure
- Time Frame: 1 Month
Safety Issue?: No
- Time Frame: 1 Month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- patients with open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- allergy to brimonidine
- inability to complete 24 hour stay for monitoring
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 80 Years
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
Overall Contact: Allergan Inc. clinicaltrials@allergan.com
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00457795
Study ID Number: MA-080806-2
ClinicalTrials.gov Identifier: NCT00457795
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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