NCT02674854

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

A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-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: 750 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

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

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-02-05
• Last updated: 2019-05-21
• Results posted: 2019-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study