To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
718
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Aerie Pharmaceuticals
Bedminster, New Jersey, United States
Intraocular Pressure (IOP)
The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.
Time frame: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
Extent of Exposure
Exposure to study medication in days for all treatment groups
Time frame: 12 months
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