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: April 5, 2012
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
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:

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
Genders Eligible for Study:   Both
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
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 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: April 5, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016