Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT03310580
Last Updated: 2019-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2017-11-15
2018-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AR-13324 Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
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%
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.04%
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Placebo Comparator
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution Placebo
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Ramirez-Davis
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals
Locations
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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
Southern California Eye Physicians Surgeons
Pasadena, California, United States
North Bay Eye Associates Inc.
Petaluma, California, United States
Martel Eye
Rancho Cordova, California, United States
University of California
San Diego, California, United States
AdvanceMed Clinical Research
San Diego, California, United States
Glaucoma Center of San Francisco
San Francisco, California, United States
Samsum Clinic
Santa Barbara, California, United States
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, United States
Jenkins Eye Care
Honolulu, Hawaii, United States
Winward Eye Physicians and Eye Surgeons
Kailua, Hawaii, United States
Island Eye Care, Inc.
Kailua, Hawaii, United States
They Eye Care Institute
Louisville, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Emil A. Stein MD Ltd
Las Vegas, Nevada, United States
AdvanceMed Clinical Research
Las Vegas, Nevada, United States
New York Eye Infirmary of Mount Sinai
New York, New York, United States
The Shimmyo Group
New York, New York, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, United States
Optimed Research
Marysville, Ohio, United States
Glaucoma Consultants and Center for Eye Research, PA
Mt. Pleasant, South Carolina, United States
University Eye Specialists
Maryville, Tennessee, United States
VRF Eye Speciality Group
Memphis, Tennessee, United States
Lake Travis Eye and Laser Center
Lakeway, Texas, United States
DCT - Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, United States
Round Rock Eye Consultants
Round Rock, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
R and R Eye Research LLC
San Antonio, Texas, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AR-13324-CS205
Identifier Type: -
Identifier Source: org_study_id