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 |
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
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
We found this trial at
40
sites
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1506 East Griffin Parkway
Mission, Texas 78572
Mission, Texas 78572
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721 Long Point Road
Mount Pleasant, South Carolina 29464
Mount Pleasant, South Carolina 29464
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