Trial · NCT04620135

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

NCT04620135, Phase 3, Completed, Aerie Pharmaceuticals; results first posted 2023-02-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT04620135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04620135

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT04620135
Status: Completed
Phases: Phase 3
Enrollment: 245 participants, actual
Lead sponsor: Aerie Pharmaceuticals
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Interventions: Netarsudil ophthalmic solution 0.02%, Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
First posted: 2020-11-06
Last updated: 2023-02-27
Results first posted: 2023-02-27

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Intraocular Pressure (IOP)	29 Days	The intent-to-treat (ITT) population was used for the primary analysis of the efficacy variables and included all randomized subjects (as randomized) who received at least 1 dose of study medication.	mmHg	LEAST_SQUARES_MEAN
SECONDARY	IOP at Weeks 1 and 2	Day 8, Day 15	ITT	mmHg	MEAN
SECONDARY	Mean Change IOP From Baseline at Days 8, 15, 29	Baseline (Day 1), Days 8, 15, 29	ITT	mmHg	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Intraocular Pressure (IOP)	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle		15.96	Standard Error 0.157	mmHg
Intraocular Pressure (IOP)	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%		17.71	Standard Error 0.155	mmHg
IOP at Weeks 1 and 2	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	Mean diurnal IOP at Weeks 1 (Days 8)	16.28	Standard Error 0.143	mmHg
IOP at Weeks 1 and 2	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	Mean diurnal IOP at Weeks 1 (Days 8)	17.87	Standard Error 0.141	mmHg
IOP at Weeks 1 and 2	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	Mean diurnal IOP at Weeks 2 (Days 15)	16.02	Standard Error 0.168	mmHg
IOP at Weeks 1 and 2	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	Mean diurnal IOP at Weeks 2 (Days 15)	17.83	Standard Error 0.166	mmHg
Mean Change IOP From Baseline at Days 8, 15, 29	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	Baseline IOP mean diurnal IOP	20.475	Standard Error 0.2510	mmHg
Mean Change IOP From Baseline at Days 8, 15, 29	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	Baseline IOP mean diurnal IOP	20.830	Standard Error 0.3198	mmHg
Mean Change IOP From Baseline at Days 8, 15, 29	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	V4: Week 1 (Day 8) Change from Baseline	-4.341	Standard Error 0.1603	mmHg
Mean Change IOP From Baseline at Days 8, 15, 29	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	V4: Week 1 (Day 8) Change from Baseline	-2.814	Standard Error 0.1397	mmHg

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Intent-to-Treat (ITT) Population	STARTED	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	122
Intent-to-Treat (ITT) Population	STARTED	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	123
Intent-to-Treat (ITT) Population	COMPLETED	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	118
Intent-to-Treat (ITT) Population	COMPLETED	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	120
Intent-to-Treat (ITT) Population	NOT COMPLETED	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	4
Intent-to-Treat (ITT) Population	NOT COMPLETED	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	3
Per-Protocol (PP) Population	STARTED	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	121
Per-Protocol (PP) Population	STARTED	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	122
Per-Protocol (PP) Population	COMPLETED	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	117
Per-Protocol (PP) Population	COMPLETED	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	119

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Conjunctival hyperaemia	Eye disorders	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	67	122
other	Conjunctival hyperaemia	Eye disorders	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	77	123
other	Eye irritation	Eye disorders	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	7	122
other	Eye irritation	Eye disorders	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	7	123
serious	Infections and infestations	Respiratory, thoracic and mediastinal disorders	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	0	122	0
serious	Infections and infestations	Respiratory, thoracic and mediastinal disorders	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	1	123	1
serious	Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	0	122	0
serious	Skin and subcutaneous tissue disorders	Skin and subcutaneous tissue disorders	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	1	123	1
serious	Treatment-Emergent Serious Adverse Event (TE-SAE)	General disorders	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	0	122	0
serious	Treatment-Emergent Serious Adverse Event (TE-SAE)	General disorders	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	2	123	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	0	122
Total, all-cause mortality	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	0	123
Total, other adverse events	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	73	122
Total, other adverse events	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	82	123
Total, serious adverse events	Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle	0	122
Total, serious adverse events	Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%	2	123

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37603205	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle vs Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%: deaths from any cause	Trial comparisons
Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution Vehicle vs Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4%: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04620135

GET https://conductscience.org/api/trials/v1/NCT04620135/flow?page=2

API reference For AI assistants