1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
Phase 3
Terminated
- Conditions
- GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT00767481
- Lead Sponsor
- Alcon Research
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Travoprost/Brinzolamide PM, Vehicle AM Travoprost/Brinzolamide Travoprost/Brinzolamide PM, Vehicle AM Travoprost/Brinzolamide AM, Vehicle PM Travoprost/Brinzolamide Travoprost/Brinzolamide AM, Vehicle PM Cosopt Cosopt Cosopt BID
- Primary Outcome Measures
Name Time Method Mean IOP 9:00,11:00, and 1600 time points at month 12
- Secondary Outcome Measures
Name Time Method 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. All on therapy time points not included in primary efficacy