NCT02057575

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

A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	PG324 Ophthalmic Solution 0.01%	1 drop in the evening (PM), once daily (QD), both eyes (OU)
DRUG	PG324 Ophthalmic Solution 0.02%	1 drop in the evening (PM), once daily (QD), both eyes (OU)
DRUG	Netarsudil (AR-13324) Ophthalmic Solution 0.02%	1 drop in the evening (PM), once daily (QD), both eyes (OU)
DRUG	Latanoprost Ophthalmic Solution 0.005%	1 drop in the evening (PM), once daily (QD), both eyes (OU)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-02-07
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study