Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.

Official Title
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A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Netarsudil ophthalmic solution 0.02%
* Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 years of age or older Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable) Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye). For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye) Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye Willingness and ability to give signed informed consent and follow study instructions Exclusion Criteria: Clinically significant ocular disease Retinal diseases that may progress during the study period Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles Previous glaucoma intraocular surgery Refractive surgery in either eye Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2 Ocular trauma Ocular infection or inflammation Any corneal disease that may confound assessment Evidence of corneal deposits or cornea verticillata Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic. Mean central corneal thickness >620 um Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus) Cannot demonstrate proper delivery of the eye drop Clinically significant systemic disease Participation in any investigational study within 30 days prior to screening Women of childbearing 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 0.02% and netarsudil ophthalmic solution vehicle<br>1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye. | Drug: Netarsudil ophthalmic solution 0.02%<br>* Topical sterile ophthalmic solution Other Name: Rhopressa®<br>* Other names: Vehicle: Netarsudil ophthalmic solution;|
| Active Comparator: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%<br>1 drop ripasudil twice daily in the morning and evening in each eye. | Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%<br>* Other Name: Glanatec®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points. | 29 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at Weeks 1 and 2 | Mean diurnal IOP as measured in mmHg at each post-treatment visit. | Day 8, Day 15 | 
| Mean Change IOP From Baseline at Days 8, 15, 29 | Mean change from baseline in mean diurnal IOP as measured in mmHg at each post-treatment visit. | Baseline (Day 1), Days 8, 15, 29 | 

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