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
NCT ID: NCT03844945
Last Updated: 2020-10-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
215 participants
INTERVENTIONAL
2019-03-19
2019-09-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT04620135
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
NCT03310580
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
NCT02874846
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
NCT03233308
Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension
NCT02207621
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Netarsudil Ophthalmic Solution 0.01%
1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.01%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.02%
1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.04%
1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution Placebo
1 drop daily into each eye in the evening for 28 days
Netarsudil Ophthalmic Solution Placebo
Topical sterile ophthalmic solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Netarsudil Ophthalmic Solution 0.01%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution Placebo
Topical sterile ophthalmic solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aerie Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenji Aso, M.D., Ph.D.
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AR-13324-CS208
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.