24-Hour IOP-Lowering Effect of Brimonidine 0.1%

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

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

Secondary Measures

  • ocular perfusion pressure
    • Time Frame: 1 Month
      Safety Issue?: No

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

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