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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
• Intervention / Treatment: Drug: AR-13324 Ophthalmic Solution 0.02%; Drug: AR-13324 Ophthalmic Solution 0.04%; Drug: AR-13324 Ophthalmic Solution Placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Eye Center
    • Phoenix, Arizona, United States, 85050
      • Arizona Glaucoma Specialists
  • California
    • Azusa, California, United States, 91702
      • Milton M. Hom, OD FAAO FACAAISc
    • Burbank, California, United States, 91506
      • Havana Research Institute
    • Glendale, California, United States, 91204
      • Global Research Management
    • Los Alamitos, California, United States, 90270
      • Southern California Eye Physicians & Surgeons
    • Los Angeles, California, United States, 90041
      • Global Research Foundation
    • Los Angeles, California, United States, 90013
      • East West Eye Institute
    • Los Angeles, California, United States, 90033
      • USC Roski Eye Institute University of Souther California
    • Newport Beach, California, United States, 92663
      • The Eye Research Foundation
    • Pasadena, California, United States, 91105
      • Southern California Eye Physicians Surgeons
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates Inc.
    • Rancho Cordova, California, United States, 95670
      • Martel Eye
    • San Diego, California, United States, 92093
      • University of California
    • San Diego, California, United States, 92122
      • AdvanceMed Clinical Research
    • San Francisco, California, United States, 94105
      • Glaucoma Center of San Francisco
    • Santa Barbara, California, United States, 93110
      • Samsum Clinic
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers LLC
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Jenkins Eye Care
    • Kailua, Hawaii, United States, 96704
      • Winward Eye Physicians and Eye Surgeons
    • Kailua, Hawaii, United States, 96740
      • Island Eye Care, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • They Eye Care Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • AdvanceMed Clinical Research
    • Las Vegas, Nevada, United States, 89119
      • Emil A. Stein MD Ltd
  • New York
    • New York, New York, United States, 10065
      • Manhattan Eye Ear and Throat Hospital
    • New York, New York, United States, 10003
      • New York Eye Infirmary of Mount Sinai
    • New York, New York, United States, 10016
      • The Shimmyo Group
  • Ohio
    • Marysville, Ohio, United States, 43040
      • Optimed Research
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Glaucoma Consultants and Center for Eye Research, PA
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38120
      • VRF Eye Speciality Group
  • Texas
    • Lakeway, Texas, United States, 78734
      • Lake Travis Eye and Laser Center
    • Mission, Texas, United States, 78572
      • DCT - Shah Research LLC dba Discovery Clinical Trials
    • Round Rock, Texas, United States, 78681
      • Round Rock Eye Consultants
    • San Antonio, Texas, United States, 78215
      • San Antonio Eye Center
    • San Antonio, Texas, United States, 78229
      • R and R Eye Research LLC
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-13324 Ophthalmic Solution 0.02%; Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days	Drug: AR-13324 Ophthalmic Solution 0.02%; Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Experimental: AR-13324 Ophthalmic Solution 0.04%; Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days	Drug: AR-13324 Ophthalmic Solution 0.04%; Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Placebo Comparator: Placebo Comparator; Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days	Drug: AR-13324 Ophthalmic Solution Placebo; Administered to each eye, once daily (QD) in the evening (PM) for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Exposure	Exposure to study medication in days for all treatment groups	28 Days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Nancy Ramirez-Davis, Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR-13324-CS205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No