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

Aerie Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: Netarsudil ophthalmic solution 0.02%; Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04620135

AR-13324-CS305

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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245 participants in 2 patient groups

Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle

Experimental group

Description:

1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.

Treatment:

Drug: Netarsudil ophthalmic solution 0.02%

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Active Comparator group

Description:

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

Treatment:

Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%