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Study of Brinzolamide and Timolol When Added to Travoprost in Primary 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: NCT00372827
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.

Condition or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma Drug: Brinzolamide 1% added to Travoprost 0.004% Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension
Study Start Date : February 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

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 diurnal intraocular pressure at month 3

Secondary Outcome Measures :
  1. Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
  2. Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
  3. Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.

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 who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion Criteria:

  • Under 18 years
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): NCT00372827


Locations
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Germany
Mainz Site
Mainz, Germany, 55131
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Anna Grau Study Manager
More Information
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Publications of Results:

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00372827    
Other Study ID Numbers: CM-03-06
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: May 2008
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