Skip to main content
OpenTrials
Completed

NCT Number: 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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nomura Eye Clinic, Ichinomiya-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be 20 years of age or older
  • Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
  • BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
  • Able and willing to give signed informed consent and following study instructions

Exclusion criteria

  • Clinically significant ocular diseases
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
  • Previous glaucoma intraocular surgery
  • Refractive surgery in either eye
  • Ocular trauma
  • Ocular infection or inflammation
  • Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
  • Cannot demonstrate proper delivery of the eye drop
  • Clinically significant abnormalities in screen lab tests
  • Clinically significant systemic disease
  • Participation in any investigational study within 30 days of screening
  • Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Treatment and study plan

Netarsudil Ophthalmic Solution 0.01%

Drug

Topical sterile ophthalmic solution

Netarsudil ophthalmic solution 0.02%

Drug

Topical sterile ophthalmic solution

Other names: Rhopressa®

Netarsudil Ophthalmic Solution 0.04%

Drug

Topical sterile ophthalmic solution

Netarsudil Ophthalmic Solution Placebo

Other

Topical sterile ophthalmic solution

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 29 Days

    Mean diurnal IOP within a treatment by Goldman Applanation Tonometry

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.