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
1 other identifier
interventional
42
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2017
Shorter than P25 for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2018
CompletedResults Posted
Study results publicly available
November 15, 2019
CompletedDecember 23, 2019
December 1, 2019
11 months
October 13, 2017
October 27, 2019
December 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
28 Days
Secondary Outcomes (1)
Extent of Exposure
28 Days
Study Arms (3)
AR-13324 Ophthalmic Solution 0.02%
EXPERIMENTALTopical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
AR-13324 Ophthalmic Solution 0.04%
EXPERIMENTALTopical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Placebo Comparator
PLACEBO COMPARATORTopical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
Interventions
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Arizona Eye Center
Chandler, Arizona, 85224, United States
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050, United States
Milton M. Hom, OD FAAO FACAAISc
Azusa, California, 91702, United States
Havana Research Institute
Burbank, California, 91506, United States
Global Research Management
Glendale, California, 91204, United States
Southern California Eye Physicians & Surgeons
Los Alamitos, California, 90270, United States
East West Eye Institute
Los Angeles, California, 90013, United States
USC Roski Eye Institute University of Souther California
Los Angeles, California, 90033, United States
Global Research Foundation
Los Angeles, California, 90041, United States
The Eye Research Foundation
Newport Beach, California, 92663, United States
Southern California Eye Physicians Surgeons
Pasadena, California, 91105, United States
North Bay Eye Associates Inc.
Petaluma, California, 94954, United States
Martel Eye
Rancho Cordova, California, 95670, United States
University of California
San Diego, California, 92093, United States
AdvanceMed Clinical Research
San Diego, California, 92122, United States
Glaucoma Center of San Francisco
San Francisco, California, 94105, United States
Samsum Clinic
Santa Barbara, California, 93110, United States
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80910, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260, United States
Jenkins Eye Care
Honolulu, Hawaii, 96814, United States
Winward Eye Physicians and Eye Surgeons
Kailua, Hawaii, 96704, United States
Island Eye Care, Inc.
Kailua, Hawaii, 96740, United States
They Eye Care Institute
Louisville, Kentucky, 40206, United States
University of Michigan
Ann Arbor, Michigan, 48105, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Emil A. Stein MD Ltd
Las Vegas, Nevada, 89119, United States
AdvanceMed Clinical Research
Las Vegas, Nevada, 89123, United States
New York Eye Infirmary of Mount Sinai
New York, New York, 10003, United States
The Shimmyo Group
New York, New York, 10016, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065, United States
Optimed Research
Marysville, Ohio, 43040, United States
Glaucoma Consultants and Center for Eye Research, PA
Mt. Pleasant, South Carolina, 29464, United States
University Eye Specialists
Maryville, Tennessee, 37803, United States
VRF Eye Speciality Group
Memphis, Tennessee, 38120, United States
Lake Travis Eye and Laser Center
Lakeway, Texas, 78734, United States
DCT - Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, 78572, United States
Round Rock Eye Consultants
Round Rock, Texas, 78681, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
R and R Eye Research LLC
San Antonio, Texas, 78229, United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22046, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy Ramirez-Davis, Director, Global Clinical Operations
- Organization
- Aerie Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Nancy Ramirez-Davis
Aerie Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2017
First Posted
October 16, 2017
Study Start
November 15, 2017
Primary Completion
October 25, 2018
Study Completion
October 25, 2018
Last Updated
December 23, 2019
Results First Posted
November 15, 2019
Record last verified: 2019-12