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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Netarsudil Ophthalmic Solution 0.01%
* Drug: Netarsudil Ophthalmic Solution 0.02%
* Drug: Netarsudil Ophthalmic Solution 0.04%
* Other: Netarsudil Ophthalmic Solution Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Netarsudil Ophthalmic Solution 0.01%<br>1 drop daily into each eye in the evening for 28 days | Drug: Netarsudil Ophthalmic Solution 0.01%<br>* Topical sterile ophthalmic solution<br>|
| Experimental: Netarsudil Ophthalmic Solution 0.02%<br>1 drop daily into each eye in the evening for 28 days | Drug: Netarsudil Ophthalmic Solution 0.02%<br>* Topical sterile ophthalmic solution<br>* Other names: Rhopressa®;|
| Experimental: Netarsudil Ophthalmic Solution 0.04%<br>1 drop daily into each eye in the evening for 28 days | Drug: Netarsudil Ophthalmic Solution 0.04%<br>* Topical sterile ophthalmic solution<br>|
| Placebo Comparator: Netarsudil Ophthalmic Solution Placebo<br>1 drop daily into each eye in the evening for 28 days | Other: Netarsudil Ophthalmic Solution Placebo<br>* Topical sterile ophthalmic solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Mean diurnal IOP within a treatment by Goldman Applanation Tonometry | 29 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Ocular Hypertension, Open-Angle Glaucoma