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

Phase 3

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Netarsudil ophthalmic solution 0.02%; Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

• Registration Number: NCT04620135
• Lead Sponsor: Aerie Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Study Start: 2020-11-30
• Primary Completion: 2021-07-09
• Study Completion: 2021-07-30
• Results First Submitted: 2022-12-13
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Results First Posted: 2023-02-27
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle	Netarsudil ophthalmic solution 0.02%	1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%	Ripasudil hydrochloride hydrate ophthalmic solution 0.4%	1 drop ripasudil twice daily in the morning and evening in each eye.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
IOP at Weeks 1 and 2	Day 8, Day 15	Mean diurnal IOP as measured in mmHg at each post-treatment visit.

Trial Locations

Locations (1)

Seijo Clinic; 🇯🇵 Setagaya-Ku, Tokyo, Japan