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

Last updated: February 1, 2023
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Open Angle Glaucoma

Ocular Hypertension

Stress

Treatment

N/A

Clinical Study ID

NCT04620135
AR-13324-CS305
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 wasacceptable)
  • Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg inboth eyes at screening visit
  • For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eyeat 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visitIOP ≥ 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 eyeat 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visitIOP ≥ 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 betteror 0.20 or better in decimal unit) in each eye
  • Willingness and ability to give signed informed consent and follow study instructions

Exclusion

Exclusion Criteria:

  • Clinically significant ocular disease
  • Retinal diseases that may progress during the study period
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closureglaucoma, 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, ornot using a medically acceptable form of birth control.

Study Design

Total Participants: 245
Study Start date:
November 30, 2020
Estimated Completion Date:
July 30, 2021

Connect with a study center

  • Seijo Clinic

    Setagaya-Ku, Tokyo
    Japan

    Site Not Available

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