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

Phase 2

Completed

• Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: AR-13324 Ophthalmic Solution 0.02%; Drug: AR-13324 Ophthalmic Solution 0.04%; Drug: AR-13324 Ophthalmic Solution Placebo

• Registration Number: NCT03310580
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Start: 2017-11-15
• Primary Completion: 2018-10-25
• Study Completion: 2018-10-25
• Results First Submitted: 2019-10-27
• Results First Submitted QC: 2019-10-27
• Results First Posted: 2019-11-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR-13324 Ophthalmic Solution 0.02%	AR-13324 Ophthalmic Solution 0.02%	Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.04%	AR-13324 Ophthalmic Solution 0.04%	Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Placebo Comparator	AR-13324 Ophthalmic Solution Placebo	Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days

Primary Outcome Measures

Name	Time	Method
Mean Diurnal IOP (Intraocular Pressure) (mmHg)	28 Days	Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).

Secondary Outcome Measures

Name	Time	Method
Extent of Exposure	28 Days	Exposure to study medication in days for all treatment groups

Trial Locations

Locations (39)

Arizona Eye Center; 🇺🇸 Chandler, Arizona, United States

Arizona Glaucoma Specialists; 🇺🇸 Phoenix, Arizona, United States

Milton M. Hom, OD FAAO FACAAISc; 🇺🇸 Azusa, California, United States

Havana Research Institute; 🇺🇸 Burbank, California, United States

Global Research Management; 🇺🇸 Glendale, California, United States

Southern California Eye Physicians & Surgeons; 🇺🇸 Los Alamitos, California, United States

East West Eye Institute; 🇺🇸 Los Angeles, California, United States

USC Roski Eye Institute University of Souther California; 🇺🇸 Los Angeles, California, United States

Global Research Foundation; 🇺🇸 Los Angeles, California, United States

The Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

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