The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
Artesia Clinical - Site 11
Artesia, California, United States
Inglewood Clinical Site - Site 15
Inglewood, California, United States
Petaluma Clinical Site - Site 17
Petaluma, California, United States
Morrow Clinical Site - Site13
Mean change from baseline in mean diurnal intraocular pressure
Time frame: 4 weeks
Mean, mean change and percent change from baseline in intraocular pressure in both mean diurnal intraocular pressure and intraocular pressure at equivalent diurnal time points.
Time frame: 4 weeks
Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables
Evaluation of safety variables including eye exam findings (best corrected visual acuity, biomicroscopy \[including grading of conjunctival hyperemia\], dilated fundus examination) adverse events, discontinuations due to adverse events, serious adverse events, and vital signs.
Time frame: 4 weeks
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Morrow, Georgia, United States
Roswell Clinical Site - Site 18
Roswell, Georgia, United States
Rochester Clinical Site - Site 12
Rochester, New York, United States
Slingerlands Clinical Site - Site 19
Slingerlands, New York, United States
Charlotte Clinical Site - Site 14
Charlotte, North Carolina, United States
High Point Clinical Site - Site 16
High Point, North Carolina, United States