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IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

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ClinicalTrials.gov Identifier: NCT00382226
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Azopt Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy
Study Start Date : September 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. IOP lowering

Secondary Outcome Measures :
  1. safety

Eligibility Criteria
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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:

  • Glaucoma

Exclusion Criteria:

  • Under 18
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382226


Locations
Australia, New South Wales
Sydney Study Site
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mark Jasek Alcon Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00382226     History of Changes
Other Study ID Numbers: CM-05-10
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: April 2008

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Travoprost
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors