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

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

sites

UNMC Stanley Truhlsen Eye Institute

Omaha, Nebraska 68106

from

Omaha, NE