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
- Conditions
- Open Angle GlaucomaOcular Hypertension
- Interventions
- Other: Netarsudil Ophthalmic Solution Placebo
- Registration Number
- NCT03844945
- Lead Sponsor
- Aerie Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Netarsudil Ophthalmic Solution 0.01% Netarsudil Ophthalmic Solution 0.01% 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution Placebo Netarsudil Ophthalmic Solution Placebo 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.02% Netarsudil Ophthalmic Solution 0.02% 1 drop daily into each eye in the evening for 28 days Netarsudil Ophthalmic Solution 0.04% Netarsudil Ophthalmic Solution 0.04% 1 drop daily into each eye in the evening for 28 days
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) 29 Days Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Yoshimura Eye & Internal Medical Clinic
🇯🇵Mishima, Shiizuoka, Japan
Tamagawa Eye Clinic
🇯🇵Ota-ku, Tokyo, Japan
Yubikai Kawaguchi Aozora Eye Clinic
🇯🇵Kawaguchi-shi, Saitama-Ken, Japan
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
🇯🇵Susono, Shizuoka-ken, Japan
Kanamori Eye Clinic
🇯🇵Akashi-shi, Hyogo, Japan
Hangai Eye Institute
🇯🇵Saitama-shi, Saitama, Japan
Sameshima Eye Clinic
🇯🇵Kagoshima-shi, Kagoshima, Japan
Asahigaoka Ophthalmology
🇯🇵Sendai-shi, Miyagi, Japan
Hashida Eye Clinic
🇯🇵Shinagawa-Ku, Tokyo, Japan
Nomura Eye Clinic
🇯🇵Ichinomiya-shi, Aichi, Japan
Omiya Hamada Eye Clinic
🇯🇵Saitama-shi, Saitama, Japan
Shibuya Ophthalmology Clinic
🇯🇵Saitama-shi, Saitama, Japan
Ueda Eye Clinic
🇯🇵Arakawa-ku, Tokyo, Japan
Ochanomizu Inoue Eye Clinic
🇯🇵Chiyoda-ku, Tokyo, Japan
Shisui ophthalmology clinic
🇯🇵Shisui, Chiba, Japan
Sugao Eye Clinic
🇯🇵Osaka-shi, Osaka, Japan
Omiya Hamada Eye Clinic West Entrance Branch
🇯🇵Saitama-shi, Saitama, Japan
Nakamori Eye Clinic
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Southern TOHOKU Eye Clinic
🇯🇵Koriyama-shi, Fukushima, Japan
Kusatsu Eye Clinic
🇯🇵Hiroshima-shi, Hiroshima, Japan
Kiyosawa Eye Clinic
🇯🇵Koto-Ku, Tokyo, Japan
Wakabadai Eye Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Seijo Clinic
🇯🇵Setagaya-Ku, Tokyo, Japan
Watanabe Eye Clinic
🇯🇵Shinagawa-Ku, Tokyo, Japan
Dogenzaka Kato Eye Clinic
🇯🇵Shibuya-ku, Tokyo, Japan