Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoproost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension...
Date First Received: October 3, 2008
Last Updated: July 10, 2009
Verified by: Alcon Research, July 2009
Clinical Trial Phase: Phase 3 | Start Date: October 2008
Overall Status: Terminated
Estimated Enrollment: 600
Brief Summary
Condition Keyword(s):
Intervention(s):
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoproost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Primary Completion Date: July 2011
Intervention(s) in this Clinical Trial
- Drug: Travoprost/Brinzolamide
- Eye drop suspension, once daily
- Drug: Cosopt
- Eye drop solution, one drop BID
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Travoprost/Brinzolamide PM, Vehicle AM
- Experimental: 2
- Travoprost/Brinzolamide AM, Vehicle PM
- Active Comparator: 3
- Cosopt BID
Outcome Measures for this Clinical Trial
Primary Measures
- Mean IOP
- Time Frame: 9:00,11:00, and 1600 time points at month 12
Safety Issue?: Yes
- Time Frame: 9:00,11:00, and 1600 time points at month 12
Secondary Measures
- Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
- Time Frame: All on therapy time points not included in primary efficacy
Safety Issue?: Yes
- Time Frame: All on therapy time points not included in primary efficacy
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits)
- 24 and ≤ 36 mmHg at 9:00
- 21 and ≤ 36 mmHg at 11:00 and 16:00
Exclusion Criteria:
- Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)
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
Additional Information
Information obtained from ClinicalTrials.gov on March 18, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00767481
Study ID Number: C-08-16
ClinicalTrials.gov Identifier: NCT00767481
Health Authority: Argentina: Ministry of Health
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