A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis



Status:Completed
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:3/14/2019
Start Date:March 2015
End Date:April 2016

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A Phase 2 Randomized, Investigator-Masked, Comparator-controlled Trial to Evaluate the Safety and Efficacy of NS2 Eye Drops in Patients With Anterior Uveitis

This is a randomized, multi-center, investigator masked, comparator controlled study. The
purpose of this study is to determine the efficacy and safety of NS2 in patients with
non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple
doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.

Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a
small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.


Inclusion Criteria:

- Non-infectious anterior uveitis

- Grade 1 - Grade 3 anterior chamber cell count

- Subjects must have Intraocular pressure <25 mmHg at baseline and may only administer a
maximum of 1 topical medication to control Intraocular pressure in the study eye.

- Visual acuity ≥ 20/200 in the study eye

Exclusion Criteria:

- Severe/serious ocular pathology

- Active intermediate or posterior uveitis.

- Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1

- Oral corticosteroids within 14 days of Visit 1

- Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6
months.
We found this trial at
15
sites
Houston, Texas 77025
573
mi
from
Houston, TX
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Ayer, Massachusetts 01940
1418
mi
from
Ayer, MA
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Birmingham, Michigan 48009
838
mi
from
Birmingham, MI
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Boston, Massachusetts 02114
1444
mi
from
Boston, MA
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Chesterfield, Missouri 63017
399
mi
from
Chesterfield, MO
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Golden, Colorado 80401
422
mi
from
Golden, CO
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Hamden, Connecticut 06518
1345
mi
from
Hamden, CT
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Kansas City, Missouri 64111
196
mi
from
Kansas City, MO
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Lancaster, California 93534
1149
mi
from
Lancaster, CA
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Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
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Omaha, Nebraska 68106
261
mi
from
Omaha, NE
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Palisades Park, New Jersey 07650
1287
mi
from
Palisades Park, NJ
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Philadelphia, Pennsylvania 19107
1225
mi
from
Philadelphia, PA
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Plantation, Florida 33324
1302
mi
from
Plantation, FL
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1435
mi
from
Waltham, MA
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