Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Primary Open Angle Glaucoma or Ocular Hypertension

Treatments: Drug: AR-13324 Ophthalmic Solution 0.02%; Drug: AR-13324 Ophthalmic Solution Placebo; Drug: AR-13324 Ophthalmic Solution 0.04%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03310580

AR-13324-CS205

Details and patient eligibility

About

To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must be 18 years or older
2. Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
4. Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
5. OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
6. OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
8. Able to give signed informed consent and follow instructions

Exclusion criteria

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
3. Intraocular pressure >/=35 mmHg in either eye
4. Ocular hyperemia score of moderate (+2) at qualification visit #2
5. Previous glaucoma intraocular surgery
6. Refractive surgery in either eye
7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
8. Recent or current ocular infection or inflammation in either eye
9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
10. Mean central corneal thickness > 620 µm in either eye
11. Any abnormality preventing reliable applanation tonometry of either eye
12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
13. Clinically significant abnormalities in screening lab tests
14. Clinically significant systemic disease that might interfere with the study
15. Participated in any investigational study within 30 days prior to screening
16. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
17. 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: Triple Blind

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42 participants in 3 patient groups, including a placebo group

AR-13324 Ophthalmic Solution 0.02%

Experimental group

Description:

Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days

Treatment:

Drug: AR-13324 Ophthalmic Solution 0.02%

AR-13324 Ophthalmic Solution 0.04%

Experimental group

Description:

Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days

Treatment:

Drug: AR-13324 Ophthalmic Solution 0.04%

Placebo Comparator

Placebo Comparator group

Description:

Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days

Treatment:

Drug: AR-13324 Ophthalmic Solution Placebo