Clinical trial NCT03844945: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Open-Angle Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-19
Enrollment: 215
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 29 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Ichinomiya-shi
country: Japan
facility: Nomura Eye Clinic
state: Aichi
city: Shisui
country: Japan
facility: Shisui ophthalmology clinic
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Nakamori Eye Clinic
state: Fukuoka
city: Koriyama-shi
country: Japan
facility: Southern TOHOKU Eye Clinic
state: Fukushima
city: Hiroshima-shi
country: Japan
facility: Kusatsu Eye Clinic
state: Hiroshima
city: Akashi-shi
country: Japan
facility: Kanamori Eye Clinic
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Sameshima Eye Clinic
state: Kagoshima
city: Sendai-shi
country: Japan
facility: Asahigaoka Ophthalmology
state: Miyagi
city: Osaka-shi
country: Japan
facility: Sugao Eye Clinic
state: Osaka
city: Kawaguchi-shi
country: Japan
facility: Yubikai Kawaguchi Aozora Eye Clinic
state: Saitama-Ken
city: Saitama-shi
country: Japan
facility: Hangai Eye Institute
state: Saitama
city: Saitama-shi
country: Japan
facility: Omiya Hamada Eye Clinic West Entrance Branch
state: Saitama
city: Saitama-shi
country: Japan
facility: Omiya Hamada Eye Clinic
state: Saitama
city: Saitama-shi
country: Japan
facility: Shibuya Ophthalmology Clinic
state: Saitama
city: Mishima
country: Japan
facility: Yoshimura Eye & Internal Medical Clinic
state: Shiizuoka
city: Susono
country: Japan
facility: Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
state: Shizuoka-ken
city: Arakawa-ku
country: Japan
facility: Ueda Eye Clinic
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Ochanomizu Inoue Eye Clinic
state: Tokyo
city: Koto-Ku
country: Japan
facility: Kiyosawa Eye Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Tamagawa Eye Clinic
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Seijo Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Dogenzaka Kato Eye Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Wakabadai Eye Clinic
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Hashida Eye Clinic
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Watanabe Eye Clinic
state: Tokyo
Study officials:
affiliation: Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
name: Kenji Aso, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.