Overview

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

Status:
Completed

Trial end date:
2019-09-19

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Aerie Pharmaceuticals

Treatments:

Ophthalmic Solutions
Pharmaceutical Solutions

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