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

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ClinicalTrials.gov Identifier: NCT00314171
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 437 participants
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
Study Start Date : October 2005
Primary Completion Date : August 2007
Study Completion Date : August 2007


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean IOP

Secondary Outcome Measures :
  1. Percent patients with IOP < 18 mmHg

Eligibility Criteria

Information from the National Library of Medicine

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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
More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00314171     History of Changes
Other Study ID Numbers: C-05-10
First Posted: April 13, 2006    Key Record Dates
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