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NCT Number: NCT04620135

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seijo Clinic

Setagaya-Ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Netarsudil ophthalmic solution 0.02%

Drug

Topical sterile ophthalmic solution Other Name: Rhopressa®

Other names: Vehicle: Netarsudil ophthalmic solution

Ripasudil hydrochloride hydrate ophthalmic solution 0.4%

Drug

Other Name: Glanatec®

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 29 Days

    Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points.

Secondary outcomes

  1. IOP at Weeks 1 and 2

    Time frame: Day 8, Day 15

    Mean diurnal IOP as measured in mmHg at each post-treatment visit.

  2. Mean Change IOP From Baseline at Days 8, 15, 29

    Time frame: Baseline (Day 1), Days 8, 15, 29

    Mean change from baseline in mean diurnal IOP as measured in mmHg at each post-treatment visit.

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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