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 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AR-13324-CS305
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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

Keywords

Glaucoma, Primary Open-Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• IOP at Weeks 1 and 2

  Day 8, Day 15

• Mean Change IOP From Baseline at Days 8, 15, 29

  Baseline (Day 1), Days 8, 15, 29

Study Arms (2)

Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle

EXPERIMENTAL

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%

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

ACTIVE COMPARATOR

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

Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Interventions

Netarsudil ophthalmic solution 0.02% DRUG

Topical sterile ophthalmic solution Other Name: Rhopressa®

Also known as: Vehicle: Netarsudil ophthalmic solution

Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle

Ripasudil hydrochloride hydrate ophthalmic solution 0.4% DRUG

Other Name: Glanatec®

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

Seijo Clinic

Setagaya-Ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 37603205 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Michelle Senchyna, PhD. VP, Clinical Development and Medical Affairs
• Organization: Aerie Pharmaceuticals Inc.

msenchyna@aeriepharma.com

+1 908-947-3551

Study Officials

• Joella Kittrell

  Aerie Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study adopted a single-masked study design. Treatment assignments were masked to the Investigator, the clinical study team (Sponsor, designated personnel involved in day-to-day study management, Monitors, Data Managers, and Statisticians), and the subjects for the duration of the study. The netarsudil and ripasudil bottles were different in the study, however, investigators and subjects were masked to study drug assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: November 30, 2020
• Primary Completion: July 9, 2021
• Study Completion: July 30, 2021
• Last Updated: February 27, 2023
• Results First Posted: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)