Phase 3
Completed N=245
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
Primary Open Angle Glaucoma · Ocular Hypertension
Source: ClinicalTrials.gov NCT04620135 ↗
Enrolled (actual)
245
Serious AEs
0.8%
Results posted
Feb 2023
Primary outcomePrimary: Intraocular Pressure (IOP) — 15.96; 17.71 mmHg — p=<0.00001
◆ Published Evidence
Emerging
15citations · ~5 / year
Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET).
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.
Linked Publications
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Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
15.96; 17.71 | <0.00001 sig |
| SECONDARY IOP at Weeks 1 and 2 |
16.28; 17.87; 16.02; 17.83 | — |
| SECONDARY Mean Change IOP From Baseline at Days 8, 15, 29 |
20.475; 20.830; -4.341; -2.814; -4.601; -2.852 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04620135) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.