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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00061529
First received: May 28, 2003
Last updated: August 4, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Brimonidine Tartrate Ophthalmic Solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Study of Brimonidine Tartrate Ophthalmic Solution, 0.15% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Study Start Date: January 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061529

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00061529     History of Changes
Other Study ID Numbers: C-02-49
Study First Received: May 28, 2003
Last Updated: August 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013