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

Primary Purpose

Primary Open Angle Glaucoma or Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.04%
AR-13324 Ophthalmic Solution Placebo
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma or Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Eye Center
  • Arizona Glaucoma Specialists
  • Milton M. Hom, OD FAAO FACAAISc
  • Havana Research Institute
  • Global Research Management
  • Southern California Eye Physicians & Surgeons
  • East West Eye Institute
  • USC Roski Eye Institute University of Souther California
  • Global Research Foundation
  • The Eye Research Foundation
  • Southern California Eye Physicians Surgeons
  • North Bay Eye Associates Inc.
  • Martel Eye
  • University of California
  • AdvanceMed Clinical Research
  • Glaucoma Center of San Francisco
  • Samsum Clinic
  • MCB Clinical Research Centers LLC
  • Clayton Eye Clinical Research, LLC
  • Jenkins Eye Care
  • Winward Eye Physicians and Eye Surgeons
  • Island Eye Care, Inc.
  • They Eye Care Institute
  • University of Michigan
  • University of Nebraska Medical Center
  • Emil A. Stein MD Ltd
  • AdvanceMed Clinical Research
  • New York Eye Infirmary of Mount Sinai
  • The Shimmyo Group
  • Manhattan Eye Ear and Throat Hospital
  • Optimed Research
  • Glaucoma Consultants and Center for Eye Research, PA
  • University Eye Specialists
  • VRF Eye Speciality Group
  • Lake Travis Eye and Laser Center
  • DCT - Shah Research LLC dba Discovery Clinical Trials
  • Round Rock Eye Consultants
  • San Antonio Eye Center
  • R and R Eye Research LLC
  • Emerson Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AR-13324 Ophthalmic Solution 0.02%

AR-13324 Ophthalmic Solution 0.04%

Placebo Comparator

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Extent of Exposure
Exposure to study medication in days for all treatment groups

Full Information

First Posted
October 13, 2017
Last Updated
December 9, 2019
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03310580
Brief Title
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma or Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR-13324 Ophthalmic Solution 0.02%
Arm Type
Experimental
Arm Description
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Arm Title
AR-13324 Ophthalmic Solution 0.04%
Arm Type
Experimental
Arm Description
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Intervention Type
Drug
Intervention Name(s)
AR-13324 Ophthalmic Solution 0.02%
Intervention Description
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Intervention Type
Drug
Intervention Name(s)
AR-13324 Ophthalmic Solution 0.04%
Intervention Description
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Intervention Type
Drug
Intervention Name(s)
AR-13324 Ophthalmic Solution Placebo
Intervention Description
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Primary Outcome Measure Information:
Title
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Description
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Extent of Exposure
Description
Exposure to study medication in days for all treatment groups
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be 18 years or older 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 Diagnosis of open-angle glaucoma or ocular hypertension in both eyes Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00 OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00 Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye Able to give signed informed consent and follow instructions Exclusion Criteria: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles Intraocular pressure >/=35 mmHg in either eye Ocular hyperemia score of moderate (+2) at qualification visit #2 Previous glaucoma intraocular surgery Refractive surgery in either eye Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening Recent or current ocular infection or inflammation in either eye Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study Mean central corneal thickness > 620 µm in either eye Any abnormality preventing reliable applanation tonometry of either eye Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution Clinically significant abnormalities in screening lab tests Clinically significant systemic disease that might interfere with the study Participated in any investigational study within 30 days prior to screening Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Ramirez-Davis
Organizational Affiliation
Aerie Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Glaucoma Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Milton M. Hom, OD FAAO FACAAISc
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Havana Research Institute
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Global Research Management
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Southern California Eye Physicians & Surgeons
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90270
Country
United States
Facility Name
East West Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
USC Roski Eye Institute University of Souther California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Global Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041
Country
United States
Facility Name
The Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Southern California Eye Physicians Surgeons
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
North Bay Eye Associates Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Martel Eye
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
AdvanceMed Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Facility Name
Glaucoma Center of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Facility Name
Samsum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
MCB Clinical Research Centers LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Jenkins Eye Care
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Winward Eye Physicians and Eye Surgeons
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96704
Country
United States
Facility Name
Island Eye Care, Inc.
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96740
Country
United States
Facility Name
They Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Emil A. Stein MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
AdvanceMed Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
New York Eye Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
The Shimmyo Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Manhattan Eye Ear and Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Optimed Research
City
Marysville
State/Province
Ohio
ZIP/Postal Code
43040
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research, PA
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
VRF Eye Speciality Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Lake Travis Eye and Laser Center
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
DCT - Shah Research LLC dba Discovery Clinical Trials
City
Mission
State/Province
Texas
ZIP/Postal Code
78572
Country
United States
Facility Name
Round Rock Eye Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
San Antonio Eye Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
R and R Eye Research LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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