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

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Netarsudil Ophthalmic Solution 0.04%; Other: Netarsudil Ophthalmic Solution Placebo; Drug: Netarsudil Ophthalmic Solution 0.01%; Drug: Netarsudil Ophthalmic Solution 0.02%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03844945

AR-13324-CS208

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 4 patient groups, including a placebo group

Netarsudil Ophthalmic Solution 0.01%

Experimental group

Description:

1 drop daily into each eye in the evening for 28 days

Treatment:

Drug: Netarsudil Ophthalmic Solution 0.01%

Netarsudil Ophthalmic Solution 0.02%

Experimental group

Description:

1 drop daily into each eye in the evening for 28 days

Treatment:

Drug: Netarsudil Ophthalmic Solution 0.02%

Netarsudil Ophthalmic Solution 0.04%

Experimental group

Description:

1 drop daily into each eye in the evening for 28 days

Treatment:

Drug: Netarsudil Ophthalmic Solution 0.04%

Netarsudil Ophthalmic Solution Placebo

Placebo Comparator group

Description:

1 drop daily into each eye in the evening for 28 days

Treatment:

Other: Netarsudil Ophthalmic Solution Placebo