Clinical trial NCT03310580: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma or Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Diurnal IOP (Intraocular Pressure) (mmHg)
timeFrame: 28 Days
Secondary outcomes:
measure: Extent of Exposure
timeFrame: 28 Days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Glaucoma Specialists
state: Arizona
city: Azusa
country: United States
facility: Milton M. Hom, OD FAAO FACAAISc
state: California
city: Burbank
country: United States
facility: Havana Research Institute
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Los Alamitos
country: United States
facility: Southern California Eye Physicians & Surgeons
state: California
city: Los Angeles
country: United States
facility: East West Eye Institute
state: California
city: Los Angeles
country: United States
facility: USC Roski Eye Institute University of Souther California
state: California
city: Los Angeles
country: United States
facility: Global Research Foundation
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Pasadena
country: United States
facility: Southern California Eye Physicians Surgeons
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc.
state: California
city: Rancho Cordova
country: United States
facility: Martel Eye
state: California
city: San Diego
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: AdvanceMed Clinical Research
state: California
city: San Francisco
country: United States
facility: Glaucoma Center of San Francisco
state: California
city: Santa Barbara
country: United States
facility: Samsum Clinic
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers LLC
state: Colorado
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Honolulu
country: United States
facility: Jenkins Eye Care
state: Hawaii
city: Kailua
country: United States
facility: Winward Eye Physicians and Eye Surgeons
state: Hawaii
city: Kailua
country: United States
facility: Island Eye Care, Inc.
state: Hawaii
city: Louisville
country: United States
facility: They Eye Care Institute
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Emil A. Stein MD Ltd
state: Nevada
city: Las Vegas
country: United States
facility: AdvanceMed Clinical Research
state: Nevada
city: New York
country: United States
facility: New York Eye Infirmary of Mount Sinai
state: New York
city: New York
country: United States
facility: The Shimmyo Group
state: New York
city: New York
country: United States
facility: Manhattan Eye Ear and Throat Hospital
state: New York
city: Marysville
country: United States
facility: Optimed Research
state: Ohio
city: Mount Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research, PA
state: South Carolina
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: VRF Eye Speciality Group
state: Tennessee
city: Lakeway
country: United States
facility: Lake Travis Eye and Laser Center
state: Texas
city: Mission
country: United States
facility: DCT - Shah Research LLC dba Discovery Clinical Trials
state: Texas
city: Round Rock
country: United States
facility: Round Rock Eye Consultants
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research LLC
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
Study officials:
affiliation: Aerie Pharmaceuticals
name: Nancy Ramirez-Davis
role: STUDY_DIRECTOR
References: