Glaucoma, Ocular Hypertension
Conditions
Keywords
glaucoma, Patients with open-angle glaucoma or ocular hypertension
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.
Interventions
DRUGCosopt
Eye drop solution, one drop BID
Eye drop suspension, once daily
Sponsors
PPD Development, LP
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP | 9:00,11:00, and 1600 time points at month 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed