NCT02558400

Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 718 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	PG324 Ophthalmic Solution 0.02%/0.005%	1 drop once daily (QD), in the evening (PM) in both eyes (OU)
DRUG	Netarsudil (AR-13324) Ophthalmic Solution 0.02%	1 drop once daily (QD), in the evening (PM) in both eyes (OU)
DRUG	Latanoprost Ophthalmic Solution 0.005%	1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Timeline

• Start date: 2015-09-18
• Primary completion: 2017-05-17
• Completion: 2017-06-30
• First posted: 2015-09-24
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study