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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00382226

First received: September 27, 2006

Last updated: November 17, 2016

Last verified: April 2008

History of Changes

Purpose

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	Intervention	Phase
Glaucoma	Drug: Azopt	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Brinzolamide Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

IOP lowering

Secondary Outcome Measures:

safety


Estimated Enrollment:	195
Study Start Date:	September 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Goldberg I, Crowston JG, Jasek MC, Stewart JA, Stewart WC; ADAPT Study Investigator Group. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012 Jan;21(1):55-9. doi: 10.1097/IJG.0b013e3181fc8142.


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00382226 History of Changes
Other Study ID Numbers:	CM-05-10
Study First Received:	September 27, 2006
Last Updated:	November 17, 2016

Keywords provided by Alcon Research:


Glaucoma

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 23, 2017

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