Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular...
Date First Received: May 8, 2007
Last Updated: April 21, 2008
Verified by: Alcon Research, April 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2007
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension”
Condition Keyword(s):
Intervention(s):
Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: Travoprost, Brinzolamide, Dorzolamide/timolol combo
Outcome Measures for this Clinical Trial
Primary Measures
- IOP
- Time Frame: Duration
- Time Frame: Duration
Secondary Measures
- Safety
- Time Frame: Evaluated during study
- Time Frame: Evaluated during study
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Written informed consent
- Diagnosis of bilateral POAG or ocular hypertension
- IOP above 19 mmHg at screening visist at 8:00 AM
- Stable visual field in last 6 months
- 6 weeks wash out from previous topical medications
Exclusion Criteria:
- Age
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 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
Marcello Fornoni Study Director Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00471380
Study ID Number: IT-04-04
ClinicalTrials.gov Identifier: NCT00471380
Health Authority: Agenzua Italiana del Farmaco: Italy
Clinical Trials Authorship and Review
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