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

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)

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: Netarsudil ophthalmic solution 0.02%; Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Setagaya-Ku, Tokyo, Japan
      • Seijo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle; 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%; Topical sterile ophthalmic solution Other Name: Rhopressa®; Other Names: Vehicle: Netarsudil ophthalmic solution
Active Comparator: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%; 1 drop ripasudil twice daily in the morning and evening in each eye.	Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%; Other Name: Glanatec®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Joella Kittrell, Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Glaucoma, Primary Open-Angle Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR-13324-CS305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No