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

Completed · Phase 2 · Has a placebo group

Conditions studied: Primary Open Angle Glaucoma or Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT03310580

Run by

Aerie Pharmaceuticals

People needed

42

Starts

2017-11-15

Expected to finish

2018-10-25

Last updated by the study team

2019-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.