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 ID: NCT04620135

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-07-30

Brief 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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Netarsudil ophthalmic solution 0.02%

Intervention Type: DRUG

Topical sterile ophthalmic solution Other Name: Rhopressa®

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

1 drop ripasudil twice daily in the morning and evening in each eye.

Group Type: ACTIVE_COMPARATOR

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Intervention Type: DRUG

Other Name: Glanatec®

Interventions

Netarsudil ophthalmic solution 0.02%

Topical sterile ophthalmic solution Other Name: Rhopressa®

Intervention Type: DRUG

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Other Name: Glanatec®

Intervention Type: DRUG

Other Intervention Names

Vehicle: Netarsudil ophthalmic solution

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 < 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joella Kittrell

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals

Locations

Seijo Clinic

Setagaya-Ku, Tokyo, Japan

Countries

Japan

References

Araie M, Sugiyama K, Aso K, Kanemoto K, Iwata R, Hollander DA, Senchyna M, Kopczynski CC. 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). Adv Ther. 2023 Oct;40(10):4639-4656. doi: 10.1007/s12325-023-02550-w. Epub 2023 Aug 21.

Reference Type: DERIVED

PMID: 37603205 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AR-13324-CS305

Identifier Type: -

Identifier Source: org_study_id