Glaucoma, Open Angle, Ocular Hypertension
Conditions
Brief summary
to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension
Interventions
DRUGXalacom
DRUGunfixed Latanoprost and Timolol
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with open-angle glaucoma or ocular hypertension
Exclusion criteria
* closed/barely open anterior chamber angle or a history of acute angel closure glaucoma * Ocular surgery within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits | — |
Countries
China
Outcome results
None listed