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

Phase 2

Completed

Interventions: Drug: NS2
Drug: Prednisolone acetate ophthalmic suspension (1%)

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
NS2	NS2	NS2 ophthalmic drops (0.5%) in the affected eye
NS2 and Pred Forte	NS2	NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
NS2 and Pred Forte	Prednisolone acetate ophthalmic suspension (1%)	NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Pred Forte	Prednisolone acetate ophthalmic suspension (1%)	Prednisolone acetate ophthalmic suspension (1%) in the affected eye

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell Grade at Week 8	The efficacy assessment period was assessed at Week 8; baseline was Day 1.	Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Metropolitan Eye Research & Surgery Institute
🇺🇸
Palisades Park, New Jersey, United States
Lifelong Vision Foundation
🇺🇸
Chesterfield, Missouri, United States
Valley Eye Physicians & Surgeons
🇺🇸
Ayer, Massachusetts, United States
Massachusetts Eye Research and Surgery Institution (MERSI)
🇺🇸
Waltham, Massachusetts, United States
Bascom Palmer Eye Institute
🇺🇸
Plantation, Florida, United States
Ophthalmic Consultants of Boston
🇺🇸
Boston, Massachusetts, United States
Colorado Retina Associates,PC
🇺🇸
Golden, Colorado, United States
Houston Eye Associates
🇺🇸
Houston, Texas, United States
Hull Eye Center
🇺🇸
Lancaster, California, United States
Eye Center of Southern Connecticut
🇺🇸
Hamden, Connecticut, United States
Oakland Ophthalmic Surgery
🇺🇸
Birmingham, Michigan, United States
Tauber Eye Center
🇺🇸
Kansas City, Missouri, United States
UNMC Stanley Truhlsen Eye Institute
🇺🇸
Omaha, Nebraska, United States
Mid-Atlantic Retina
🇺🇸
Philadelphia, Pennsylvania, United States
Virginia Eye Consultants
🇺🇸
Norfolk, Virginia, United States