The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension...
Date First Received: May 28, 2003
Last Updated: August 4, 2008
Verified by: Alcon Research, August 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2003
Overall Status: Completed
Brief Summary
Official Title: “A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension”
Condition Keyword(s):
Intervention(s):
The primary objective of this study is to compare the safety and efficacy of Brimonidine Tartrate Ophthalmic Solution, 0.15% in patients with open-angle glaucoma or ocular hypertension.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: July 2004
Intervention(s) in this Clinical Trial
- Drug: Brimonidine Tartrate Ophthalmic Solution
Criteria for Participation in this Clinical Trial
- Patients of any race
- two (2) years of age or older
- of either sex
- diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)or ocular hypertension
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 2 Months
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00061529
Study ID Number: C-02-49
ClinicalTrials.gov Identifier: NCT00061529
Health Authority: United States: Food and Drug Administration
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