NCT02558374

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 708 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	AR-13324 Ophthalmic Solution 0.02%	1 drop once daily (QD), PM, OU
DRUG	Timolol Maleate Ophthalmic Solution 0.5% BID	1 drop BID, AM/PM, OU
OTHER	Placebo	1 drop QD, AM, OU

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-09-24
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

1 site across 1 country: United States