Phase 2
Completed N=215
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
Source: ClinicalTrials.gov NCT03844945 ↗Enrolled (actual)
215
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Intraocular Pressure (IOP) — 20.5; 20.3; 20.8; 21.1 mmHg — p=<0.0001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
20.5; 20.3; 20.8; 21.1; 16.2; 15.9 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03844945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.