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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT04620135•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Seijo Clinic

Setagaya-Ku, Tokyo, Japan

Key Dates

Start Date

November 30, 2020

Primary Completion Date

July 9, 2021

Completion Date

July 30, 2021

Last Updated

February 27, 2023

Enrollment

245

ACTUAL participants

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Interventions

Netarsudil ophthalmic solution 0.02%

DRUG

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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RECRUITINGNA

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

NCT05902871

Primary Open Angle GlaucomaOcular Hypertension+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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