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
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Netarsudil ophthalmic solution 0.02%; Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
Intervention description: Topical sterile ophthalmic solution Other Name: Rhopressa®; Other Name: Glanatec®
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: 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.
Enrollment: 245.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Glaucoma, Primary Open-Angle Glaucoma; Ocular Hypertension

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 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.