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

Primary Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310580
• Other study ID #: AR-13324-CS205
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2017
• Est. completion date: October 25, 2018

Study information

• Verified date: December 2019
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• AR-13324 Ophthalmic Solution 0.02%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
• AR-13324 Ophthalmic Solution 0.04%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
• AR-13324 Ophthalmic Solution Placebo
Administered to each eye, once daily (QD) in the evening (PM) for 28 days

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Milton M. Hom, OD FAAO FACAAISc	Azusa	California
United States	Havana Research Institute	Burbank	California
United States	Arizona Eye Center	Chandler	Arizona
United States	MCB Clinical Research Centers LLC	Colorado Springs	Colorado
United States	Emerson Clinical Research Institute	Falls Church	Virginia
United States	Global Research Management	Glendale	California
United States	Jenkins Eye Care	Honolulu	Hawaii
United States	Island Eye Care, Inc.	Kailua	Hawaii
United States	Winward Eye Physicians and Eye Surgeons	Kailua	Hawaii
United States	Lake Travis Eye and Laser Center	Lakeway	Texas
United States	AdvanceMed Clinical Research	Las Vegas	Nevada
United States	Emil A. Stein MD Ltd	Las Vegas	Nevada
United States	Southern California Eye Physicians & Surgeons	Los Alamitos	California
United States	East West Eye Institute	Los Angeles	California
United States	Global Research Foundation	Los Angeles	California
United States	USC Roski Eye Institute University of Souther California	Los Angeles	California
United States	They Eye Care Institute	Louisville	Kentucky
United States	Optimed Research	Marysville	Ohio
United States	University Eye Specialists	Maryville	Tennessee
United States	VRF Eye Speciality Group	Memphis	Tennessee
United States	DCT - Shah Research LLC dba Discovery Clinical Trials	Mission	Texas
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Glaucoma Consultants and Center for Eye Research, PA	Mount Pleasant	South Carolina
United States	Manhattan Eye Ear and Throat Hospital	New York	New York
United States	New York Eye Infirmary of Mount Sinai	New York	New York
United States	The Shimmyo Group	New York	New York
United States	The Eye Research Foundation	Newport Beach	California
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Southern California Eye Physicians Surgeons	Pasadena	California
United States	North Bay Eye Associates Inc.	Petaluma	California
United States	Arizona Glaucoma Specialists	Phoenix	Arizona
United States	Martel Eye	Rancho Cordova	California
United States	Round Rock Eye Consultants	Round Rock	Texas
United States	R and R Eye Research LLC	San Antonio	Texas
United States	San Antonio Eye Center	San Antonio	Texas
United States	AdvanceMed Clinical Research	San Diego	California
United States	University of California	San Diego	California
United States	Glaucoma Center of San Francisco	San Francisco	California
United States	Samsum Clinic	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Diurnal IOP (Intraocular Pressure) (mmHg)	Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).	28 Days
Secondary	Extent of Exposure	Exposure to study medication in days for all treatment groups	28 Days