Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Verified by: Allergan, April 2008
First Received: April 1, 2008 | Last Updated: April 1, 2008 | Phase: Phase 3 | Start Date: May 2003
Overall Status: Completed | Estimated Enrollment: 433
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This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular...

Brief Summary

This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

  • Drug: Brimonidine ophthalmic solution 0.1%
    • 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
  • Drug: Brimonidine ophthalmic solution 0.2%
    • 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Brimonidine ophthalmic solution 0.1%
  • Active Comparator: 2
    • Brimonidine ophthalmic solution 0.2%

Outcome Measures for this Clinical Trial

Primary Measures

  • Intraocular pressure (IOP)
    • Time Frame: Week 2 - Month 3
      Safety Issue?: No

Secondary Measures

  • IOP
    • Time Frame: Month 6 - Month 12
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Known allergy or sensitivity to brimonidine

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 Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652483

Study ID Number: 190342-021

ClinicalTrials.gov Identifier: NCT00652483

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00652483