In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
234
PG286 Ophthalmic Solution
AR-12286 Ophthalmic Solution 0.5%
Travoprost Ophthalmic Solution 0.004%
Kenneth Sall, M.D.
Artesia, California, United States
Mean diurnal IOP
The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.
Time frame: 28 Days
IOP
Secondary efficacy endpoints will include: mean IOP across subjects within treatment group at each post-treatment timepoint, mean change from diurnally adjusted baseline IOP at each timepoint, mean percent change from diurnally adjusted baseline IOP at each timepoint, mean diurnal IOP at other visits, and mean change from the baseline mean diurnal IOP at each visits.
Time frame: 7-28 days
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