The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension...
Date First Received: September 10, 2007
Last Updated: February 4, 2008
Verified by: Alcon Research, February 2008
Clinical Trial Phase: Phase 2 | Start Date: August 2007
Overall Status: Completed
Estimated Enrollment: 125
Brief Summary
Official Title: “IOP Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma or Ocular Hypertension”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in patients with open-angle glaucoma or ocular hypertension.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Travoprost/brinzolamide
Outcome Measures for this Clinical Trial
Primary Measures
- Mean IOP
- Time Frame: Time
- Time Frame: Time
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension
Exclusion Criteria:
- Age (Under 18)
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
Theresa Landry Study Director Alcon Research
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00527501
Study ID Number: C-07-07
ClinicalTrials.gov Identifier: NCT00527501
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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