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IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension

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.
 
ClinicalTrials.gov Identifier: NCT00527501
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost/brinzolamide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : August 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Mean IOP [ Time Frame: Time ]

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

Exclusion Criteria:

  • Age (Under 18)
Contacts and Locations
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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): NCT00527501


Locations
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United States, California
Artesia
Artesia, California, United States, 90701
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Theresa Landry Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00527501    
Other Study ID Numbers: C-07-07
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: February 2008
Keywords provided by Alcon Research:
Open-angle glaucoma
ocular hypertension
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
 Travoprost
Brinzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action