Status:
COMPLETED
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
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03844945
Start Date
March 19 2019
End Date
September 19 2019
Last Update
October 19 2020
Active Locations (25)
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1
Nomura Eye Clinic
Ichinomiya-shi, Aichi-ken, Japan
2
Shisui ophthalmology clinic
Shisui, Chiba, Japan
3
Nakamori Eye Clinic
Kitakyushu-shi, Fukuoka, Japan
4
Southern TOHOKU Eye Clinic
Koriyama-shi, Fukushima, Japan