This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
QD and/or BID dosing for 28 days
QD and/or BID dosing for 28 days
QD and/or BID dosing for 28 days
QD and/or BID dosing for 28 days
QD and/or BID dosing for 28 days
QD and/or BID dosing for 4 days
QD and/or BID dosing for 4 days
0.5%
Unnamed facility
Artesia, California, United States
Unnamed facility
Glendale, California, United States
Unnamed facility
Saint Joseph, Michigan, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
San Antonio, Texas, United States
Mean Change in Intraocular Pressure from Baseline
Time frame: Stage 1: Days 14, 21 and 28; Stage 2: Day 4
Observed Intraocular Pressure and % change from Baseline IOP
Time frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
Mean observed, mean change from Baseline and mean % change from Baseline for the mean diurnal IOP
Time frame: Stage 1: Days 0, 1, 4, 14, 21, 28; Stage 2: Days 0, 4
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