To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects. Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
147
Unnamed facility
Austin, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Intraocular pressure (IOP)
Change from baseline in mean diurnal IOP
Time frame: 29 days
Intraocular pressure (IOP)
Percent change from baseline in mean diurnal IOP
Time frame: 29 days
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Topical ocular solution
Topical ocular solution
Topical ocular solution