This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Unnamed facility
Austin, Texas, United States
Change From Baseline in Average Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.
Time frame: Baseline, Day 57
Change From Baseline in Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.
Time frame: Baseline, Day 57
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