24-hour IOP-lowering Effect of Brimonidine 0.1%

Verified by: Allergan, October 2011
First Received: April 6, 2007 | Last Updated: October 18, 2011 | Phase: Phase 4 | Start Date: December 2006
Overall Status: Completed | Estimated Enrollment: 15
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This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular...

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: February 2009

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: brimonidine 0.1%
    • brimonidine 0.1%

Outcome Measures for this Clinical Trial

Primary Measures

  • Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
    • Time Frame: Week 4
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
    • Time Frame: Baseline, Week 4
      Safety Issue?: No
  • Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
    • Time Frame: Week 4
      Safety Issue?: No
  • Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
    • Time Frame: Week 4
      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 Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Affairs Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00457795