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

Sponsor
Aerie Pharmaceuticals
Study ID
NCT04620135
Phase
PHASE3
Status
Completed

Conditions

  • Ocular Hypertension
  • Primary Open Angle Glaucoma

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Netarsudil ophthalmic solution 0.02% — DRUG
    Topical sterile ophthalmic solution Other Name: Rhopressa®
  • Ripasudil hydrochloride hydrate ophthalmic solution 0.4% — DRUG
    Other Name: Glanatec®

Study Details

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.

Key Dates

Start date
Nov 30, 2020
Status verified
Feb 2023
Primary completion
Jul 9, 2021
Completion
Jul 30, 2021

Study Design

Enrollment
245 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
    1 drop ripasudil twice daily in the morning and evening in each eye.

Primary Outcome Measure

Intraocular Pressure (IOP) [ Time Frame: 29 Days ]

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