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A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314171
First Posted: April 13, 2006
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Open-angle Glaucoma Ocular Hypertension Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP

Secondary Outcome Measures:
  • Percent patients with IOP < 18 mmHg

Enrollment: 437
Study Start Date: October 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide + Timolol Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension
One drop in the study eye(s) twice daily for 12 months
Active Comparator: Dorzolamide + Timolol Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)
One drop in the study eye(s) twice daily for 12 months
Other Name: COSOPT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Under 18
  • Pregnant
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00314171     History of Changes
Other Study ID Numbers: C-05-10
First Submitted: April 10, 2006
First Posted: April 13, 2006
Last Update Posted: November 18, 2016
Last Verified: March 2012

Keywords provided by Alcon Research:
open-angle glaucoma
ocular hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Timolol
Dorzolamide
Brinzolamide
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors