A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

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”

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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