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
1 other identifier
interventional
215
1 country
25
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
March 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
September 1, 2020
6 months
February 15, 2019
September 23, 2020
September 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure (IOP)
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
29 Days
Study Arms (4)
Netarsudil Ophthalmic Solution 0.01%
EXPERIMENTAL1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.02%
EXPERIMENTAL1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.04%
EXPERIMENTAL1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution Placebo
PLACEBO COMPARATOR1 drop daily into each eye in the evening for 28 days
Interventions
Topical sterile ophthalmic solution
Topical sterile ophthalmic solution
Topical sterile ophthalmic solution
Topical sterile ophthalmic solution
Eligibility Criteria
You may qualify if:
- Must be 20 years of age or older
- 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)
- BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
- Able and willing to give signed informed consent and following study instructions
You may not qualify if:
- Clinically significant ocular diseases
- Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular trauma
- Ocular infection or inflammation
- Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
- Cannot demonstrate proper delivery of the eye drop
- Clinically significant abnormalities in screen lab tests
- Clinically significant systemic disease
- Participation in any investigational study within 30 days of screening
- Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Nomura Eye Clinic
Ichinomiya-shi, Aichi-ken, Japan
Shisui ophthalmology clinic
Shisui, Chiba, Japan
Nakamori Eye Clinic
Kitakyushu-shi, Fukuoka, Japan
Southern TOHOKU Eye Clinic
Koriyama-shi, Fukushima, Japan
Kusatsu Eye Clinic
Hiroshima, Hiroshima, Japan
Kanamori Eye Clinic
Akashi-shi, Hyōgo, Japan
Sameshima Eye Clinic
Kagoshima, Kagoshima-ken, Japan
Asahigaoka Ophthalmology
Sendai, Miyagi, Japan
Sugao Eye Clinic
Osaka, Osaka, Japan
Yubikai Kawaguchi Aozora Eye Clinic
Kawaguchi-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-shi, Saitama, Japan
Yoshimura Eye & Internal Medical Clinic
Mishima, Shiizuoka, Japan
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
Susono, Shizuoka, Japan
Ueda Eye Clinic
Arakawa-ku, Tokyo, Japan
Ochanomizu Inoue Eye Clinic
Chiyoda-ku, Tokyo, Japan
Kiyosawa Eye Clinic
Koto-Ku, Tokyo, Japan
Tamagawa Eye Clinic
Ōta-ku, Tokyo, Japan
Seijo Clinic
Setagaya-Ku, Tokyo, Japan
Dogenzaka Kato Eye Clinic
Shibuya-ku, Tokyo, Japan
Wakabadai Eye Clinic
Shibuya-ku, Tokyo, Japan
Hashida Eye Clinic
Shinagawa-Ku, Tokyo, Japan
Watanabe Eye Clinic
Shinagawa-Ku, Tokyo, Japan
Related Publications (1)
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.
PMID: 33629227DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research, Japan
- Organization
- Aerie Pharmaceuticals Ireland Limited, Japan Branch
Study Officials
- STUDY DIRECTOR
Kenji Aso, M.D., Ph.D.
Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 19, 2019
Study Start
March 19, 2019
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2020-09