Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
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)
VRF Eye Speciality Group
🇺🇸Memphis, Tennessee, United States
Southern California Eye Physicians & Surgeons
🇺🇸Los Alamitos, California, United States
Round Rock Eye Consultants
🇺🇸Round Rock, Texas, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Manhattan Eye Ear and Throat Hospital
🇺🇸New York, New York, United States
Winward Eye Physicians and Eye Surgeons
🇺🇸Kailua, Hawaii, United States
DCT - Shah Research LLC dba Discovery Clinical Trials
🇺🇸Mission, Texas, United States
Global Research Management
🇺🇸Glendale, California, United States
The Eye Research Foundation
🇺🇸Newport Beach, California, United States
New York Eye Infirmary of Mount Sinai
🇺🇸New York, New York, United States
Martel Eye
🇺🇸Rancho Cordova, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
MCB Clinical Research Centers LLC
🇺🇸Colorado Springs, Colorado, United States
The Shimmyo Group
🇺🇸New York, New York, United States
Samsum Clinic
🇺🇸Santa Barbara, California, United States
Glaucoma Consultants and Center for Eye Research, PA
🇺🇸Mount Pleasant, South Carolina, United States
Southern California Eye Physicians Surgeons
🇺🇸Pasadena, California, United States
Emerson Clinical Research Institute
🇺🇸Falls Church, Virginia, United States
Glaucoma Center of San Francisco
🇺🇸San Francisco, California, United States
Island Eye Care, Inc.
🇺🇸Kailua, Hawaii, United States
R and R Eye Research LLC
🇺🇸San Antonio, Texas, United States
Emil A. Stein MD Ltd
🇺🇸Las Vegas, Nevada, United States
Milton M. Hom, OD FAAO FACAAISc
🇺🇸Azusa, California, United States
Havana Research Institute
🇺🇸Burbank, California, United States
Global Research Foundation
🇺🇸Los Angeles, California, United States
USC Roski Eye Institute University of Souther California
🇺🇸Los Angeles, California, United States
North Bay Eye Associates Inc.
🇺🇸Petaluma, California, United States
Jenkins Eye Care
🇺🇸Honolulu, Hawaii, United States
They Eye Care Institute
🇺🇸Louisville, Kentucky, United States
University Eye Specialists
🇺🇸Maryville, Tennessee, United States
Lake Travis Eye and Laser Center
🇺🇸Lakeway, Texas, United States
San Antonio Eye Center
🇺🇸San Antonio, Texas, United States
East West Eye Institute
🇺🇸Los Angeles, California, United States
University of California
🇺🇸San Diego, California, United States
Arizona Glaucoma Specialists
🇺🇸Phoenix, Arizona, United States
AdvanceMed Clinical Research
🇺🇸Las Vegas, Nevada, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Optimed Research
🇺🇸Marysville, Ohio, United States