Safety and Efficacy Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04620135

Collaborator

(none)

245

Enrollment

Location

Arms

8.5

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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 Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma Ocular Hypertension	Drug: Netarsudil ophthalmic solution 0.02% Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

245 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Masking Description:

This study adopts a single-masked study design. Therefore, to ensure masked state to the investigators and the clinical study team, the study medication bottles are placed in a sealed kit so that the study medication cannot be identified from the outside of the kit.

Primary Purpose:

Treatment

Official Title:

A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Actual Study Start Date :

Nov 12, 2020

Actual Primary Completion Date :

Jul 9, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Netarsudil ophthalmic solution 0.02% Topical sterile ophthalmic solution Other Name: Rhopressa® Other Names: Netarsudil ophthalmic solution Vehicle
Active Comparator: Ripasudil hydrochloride hydrate ophthalmic solution 0.4% 1 drop ripasudil twice dairy in the morning and evening in each eye.	Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4% Other Name: Glanatec®

Arm

Intervention/Treatment

Experimental: 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.

Drug: Netarsudil ophthalmic solution 0.02%

Topical sterile ophthalmic solution Other Name: Rhopressa®

Other Names:

Netarsudil ophthalmic solution Vehicle

Active Comparator: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

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

Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Other Name: Glanatec®

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [29 Days]
Mean diurnal IOP by treatment group by Goldmann applanation tonometry

Secondary Outcome Measures

Intraocular Pressure (IOP) at Weeks 1 and 2 [15 Days]
Mean diurnal IOP at Weeks 1 and 2 (Days 8 and 15, respectively)
Mean Change From Baseline IOP [29 Days]
Mean change from baseline in mean diurnal IOP at each post-treatment visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 is acceptable)
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
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Previous glaucoma intraocular surgery
Refractive surgery in either eye
Ocular trauma
Ocular infection
Any corneal disease
Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
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.