NCT03844945

Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Aerie Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Netarsudil Ophthalmic Solution 0.01%	Topical sterile ophthalmic solution
DRUG	Netarsudil Ophthalmic Solution 0.02%	Topical sterile ophthalmic solution
DRUG	Netarsudil Ophthalmic Solution 0.04%	Topical sterile ophthalmic solution
OTHER	Netarsudil Ophthalmic Solution Placebo	Topical sterile ophthalmic solution

Timeline

• Start date: 2019-03-19
• Primary completion: 2019-09-19
• Completion: 2019-09-19
• First posted: 2019-02-19
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

25 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study