Glaucoma, Open Angle, Ocular Hypertension
Conditions
Brief summary
To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening
Exclusion criteria
* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. * History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean IOP measurements obtained in the study eye at each time point | — |
Countries
France, Germany, Greece, Italy, Sweden
Outcome results
None listed