NCT03310580

Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.

Conditions

• Primary Open Angle Glaucoma or Ocular Hypertension

Interventions

Type	Name	Description
DRUG	AR-13324 Ophthalmic Solution 0.02%	Administered to each eye, once daily (QD) in the evening (PM) for 28 days
DRUG	AR-13324 Ophthalmic Solution 0.04%	Administered to each eye, once daily (QD) in the evening (PM) for 28 days
DRUG	AR-13324 Ophthalmic Solution Placebo	Administered to each eye, once daily (QD) in the evening (PM) for 28 days

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2017-10-16
• Last updated: 2019-12-23
• Results posted: 2019-11-15

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study