Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: Netarsudil Ophthalmic Solution 0.01%; Drug: Netarsudil Ophthalmic Solution 0.02%; Drug: Netarsudil Ophthalmic Solution 0.04%; Other: Netarsudil Ophthalmic Solution Placebo

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Ichinomiya-shi, Aichi, Japan
      • Nomura Eye Clinic
  • Chiba
    • Shisui, Chiba, Japan
      • Shisui Ophthalmology Clinic
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan
      • Nakamori Eye Clinic
  • Fukushima
    • Koriyama-shi, Fukushima, Japan
      • Southern Tohoku Eye Clinic
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan
      • Kusatsu Eye Clinic
  • Hyogo
    • Akashi-shi, Hyogo, Japan
      • Kanamori Eye Clinic
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan
      • Sameshima Eye Clinic
  • Miyagi
    • Sendai-shi, Miyagi, Japan
      • Asahigaoka Ophthalmology
  • Osaka
    • Osaka-shi, Osaka, Japan
      • Sugao Eye Clinic
  • Saitama
    • Saitama-shi, Saitama, Japan
      • Hangai Eye Institute
    • Saitama-shi, Saitama, Japan
      • Omiya Hamada Eye Clinic West entrance Branch
    • Saitama-shi, Saitama, Japan
      • Omiya Hamada Eye Clinic
    • Saitama-shi, Saitama, Japan
      • Shibuya Ophthalmology Clinic
  • Saitama-Ken
    • Kawaguchi-shi, Saitama-Ken, Japan
      • Yubikai Kawaguchi Aozora Eye Clinic
  • Shiizuoka
    • Mishima, Shiizuoka, Japan
      • Yoshimura Eye & Internal Medical Clinic
  • Shizuoka-ken
    • Susono, Shizuoka-ken, Japan
      • Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
  • Tokyo
    • Arakawa-ku, Tokyo, Japan
      • Ueda Eye Clinic
    • Chiyoda-ku, Tokyo, Japan
      • Ochanomizu Inoue Eye Clinic
    • Koto-Ku, Tokyo, Japan
      • Kiyosawa Eye Clinic
    • Ota-ku, Tokyo, Japan
      • Tamagawa Eye Clinic
    • Setagaya-Ku, Tokyo, Japan
      • Seijo Clinic
    • Shibuya-ku, Tokyo, Japan
      • Dogenzaka Kato Eye Clinic
    • Shibuya-ku, Tokyo, Japan
      • Wakabadai Eye Clinic
    • Shinagawa-Ku, Tokyo, Japan
      • Hashida Eye Clinic
    • Shinagawa-Ku, Tokyo, Japan
      • Watanabe Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must be 20 years of age or older
2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
4. Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

1. Clinically significant ocular diseases
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
3. Previous glaucoma intraocular surgery
4. Refractive surgery in either eye
5. Ocular trauma
6. Ocular infection or inflammation
7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
8. Cannot demonstrate proper delivery of the eye drop
9. Clinically significant abnormalities in screen lab tests
10. Clinically significant systemic disease
11. Participation in any investigational study within 30 days of screening
12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Netarsudil Ophthalmic Solution 0.01%; 1 drop daily into each eye in the evening for 28 days	Drug: Netarsudil Ophthalmic Solution 0.01%; Topical sterile ophthalmic solution
Experimental: Netarsudil Ophthalmic Solution 0.02%; 1 drop daily into each eye in the evening for 28 days	Drug: Netarsudil Ophthalmic Solution 0.02%; Topical sterile ophthalmic solution; Other Names: Rhopressa®
Experimental: Netarsudil Ophthalmic Solution 0.04%; 1 drop daily into each eye in the evening for 28 days	Drug: Netarsudil Ophthalmic Solution 0.04%; Topical sterile ophthalmic solution
Placebo Comparator: Netarsudil Ophthalmic Solution Placebo; 1 drop daily into each eye in the evening for 28 days	Other: Netarsudil Ophthalmic Solution Placebo; Topical sterile ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	Mean diurnal IOP within a treatment by Goldman Applanation Tonometry	29 Days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Kenji Aso, M.D., Ph.D., Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)

Publications and helpful links

General Publications

• Araie M, Sugiyama K, Aso K, Kanemoto K, Kothapalli K, Kopczynski C, Senchyna M, Hollander DA. Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2021 Apr;38(4):1757-1775. doi: 10.1007/s12325-021-01634-9. Epub 2021 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): September 19, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Open-Angle Glaucoma; Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR-13324-CS208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes