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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:November 15, 2017
End Date:October 25, 2018

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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

To test the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution
relative to placebo in Japanese/Japanese-American subjects with elevated intraocular pressure


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
study duration

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
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Maryville, Tennessee 37803
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San Francisco, California 94105
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Azusa, California 91702
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Burbank, California 91506
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Chandler, Arizona
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Colorado Springs, Colorado 80910
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2516 Sheridan Road Southeast
Falls Church, Virginia 22046
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Glendale, California 91204
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Honolulu, Hawaii 96814
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Kailua, Hawaii 96740
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401 Ranch Road 620 South
Lakeway, Texas 78734
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7730 West Cheyenne Avenue
Las Vegas, Nevada 89129
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Los Alamitos, California 90270
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Los Angeles, California 90013
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Los Angeles, California 90041
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Louisville, Kentucky 40206
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Marysville, Ohio 43040
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Memphis, Tennessee 38120
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1506 East Griffin Parkway
Mission, Texas 78572
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1000 Corporate Center Drive
Morrow, Georgia 30260
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721 Long Point Road
Mount Pleasant, South Carolina 29464
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New York, New York 10003
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Newport Beach, California
Phone: 949-650-1863
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Pasadena, California 91105
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Petaluma, California 94954
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Phoenix, Arizona 85050
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Rancho Cordova, California 95670
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Round Rock, Texas 78681
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San Antonio, Texas 78215
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San Diego, California 92103
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Santa Barbara, California 93105
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