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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.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00372827
First received: September 6, 2006
Last updated: April 5, 2012
Last verified: May 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372827

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00372827     History of Changes
Other Study ID Numbers: CM-03-06
Study First Received: September 6, 2006
Last Updated: April 5, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brinzolamide
 Travoprost
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013