Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Summary

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Timeline

Start

2014-01

Primary completion

2014-06

Completion

2014-06

Outcome

Met primary endpoint

paper For the primary efficacy variable of mean diurnal IOP at day 29, PG324 0.02% met the criterion for statistical superiority relative to both latanoprost and AR-13324 0.02% (p<0.0001) PMID 26209587 ↗

registry analysis (superiority test); PG324 Ophthalmic Solution 0.02% vs Netarsudil (AR-13324) Ophthalmic Solution; p <0.0001; t-test, 2 sided NCT02057575 ↗

registry analysis (superiority test); PG324 Ophthalmic Solution 0.02% vs Latanoprost Ophthalmic Solution; p <0.0001; t-test, 2 sided NCT02057575 ↗

Publications

• Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Latanoprost	Small molecule	0.005 %	—
Subject	Netarsudil	Small molecule	0.01 %	—
Subject	Netarsudil	Small molecule	0.02 %	—

Indications