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...
Date First Received: September 6, 2006
Last Updated: May 22, 2008
Verified by: Alcon Research, May 2008
Clinical Trial Phase: Phase 4 | Start Date: February 2004
Overall Status: Completed
Estimated Enrollment: 245
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Brinzolamide 1% added to Travoprost 0.004%
Outcome Measures for this Clinical Trial
Primary Measures
- Mean diurnal intraocular pressure at month 3
Secondary 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.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Alcon Research
Overall Clinical Trial Officials and Contacts
Anna Grau Study Director Study Manager
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372827
Study ID Number: CM-03-06
ClinicalTrials.gov Identifier: NCT00372827
Health Authority: Germany: Ethics Commission
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
