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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844945
• Other study ID #: AR-13324-CS208
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2019
• Est. completion date: September 19, 2019

Study information

• Verified date: September 2020
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• 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

Other:
• Netarsudil Ophthalmic Solution Placebo
Topical sterile ophthalmic solution

Locations

Country	Name	City	State
Japan	Kanamori Eye Clinic	Akashi-shi	Hyogo
Japan	Ueda Eye Clinic	Arakawa-ku	Tokyo
Japan	Ochanomizu Inoue Eye Clinic	Chiyoda-ku	Tokyo
Japan	Kusatsu Eye Clinic	Hiroshima-shi	Hiroshima
Japan	Nomura Eye Clinic	Ichinomiya-shi	Aichi
Japan	Sameshima Eye Clinic	Kagoshima-shi	Kagoshima
Japan	Yubikai Kawaguchi Aozora Eye Clinic	Kawaguchi-shi	Saitama-Ken
Japan	Nakamori Eye Clinic	Kitakyushu-shi	Fukuoka
Japan	Southern TOHOKU Eye Clinic	Koriyama-shi	Fukushima
Japan	Kiyosawa Eye Clinic	Koto-Ku	Tokyo
Japan	Yoshimura Eye & Internal Medical Clinic	Mishima	Shiizuoka
Japan	Sugao Eye Clinic	Osaka-shi	Osaka
Japan	Tamagawa Eye Clinic	Ota-ku	Tokyo
Japan	Hangai Eye Institute	Saitama-shi	Saitama
Japan	Omiya Hamada Eye Clinic	Saitama-shi	Saitama
Japan	Omiya Hamada Eye Clinic West Entrance Branch	Saitama-shi	Saitama
Japan	Shibuya Ophthalmology Clinic	Saitama-shi	Saitama
Japan	Asahigaoka Ophthalmology	Sendai-shi	Miyagi
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	Shisui ophthalmology clinic	Shisui	Chiba
Japan	Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic	Susono	Shizuoka-ken

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	Mean diurnal IOP within a treatment by Goldman Applanation Tonometry	29 Days