1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
Overview
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 Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: February 2009
Interventions
- Drug: Travoprost/Brinzolamide
- Eye drop suspension, once daily
- Drug: Cosopt
- Eye drop solution, one drop BID
Arms, Groups and Cohorts
- Experimental: Travoprost/Brinzolamide PM, Vehicle AM
- Travoprost/Brinzolamide PM, Vehicle AM
- Experimental: Travoprost/Brinzolamide AM, Vehicle PM
- Travoprost/Brinzolamide AM, Vehicle PM
- Active Comparator: Cosopt
- Cosopt BID
Clinical Trial Outcome Measures
Primary Measures
- Mean IOP
- 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
Participating 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: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alcon Research
- Collaborator
- PPD
- Provider of Information About this Clinical Study
- Sponsor
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