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Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: September 6, 2006
Last updated: November 18, 2016
Last verified: May 2008
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 Intervention Phase
Primary Open-angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma Drug: Brinzolamide 1% added to Travoprost 0.004% Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean diurnal intraocular pressure at month 3

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

Estimated Enrollment: 245
Study Start Date: February 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00372827

Mainz Site
Mainz, Germany, 55131
Sponsors and Collaborators
Alcon Research
Study Director: Anna Grau Study Manager
  More Information

Responsible Party: Alcon Research Identifier: NCT00372827     History of Changes
Other Study ID Numbers: CM-03-06
Study First Received: September 6, 2006
Last Updated: November 18, 2016

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
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 processed this record on August 18, 2017