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

Aldeyra Therapeutics, Inc.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-infectious Anterior Uveitis

Interventions

NS2DRUG

NS2 ophthalmic drops (0.5%)

Prednisolone acetate ophthalmic suspension (1%)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (15)

Hull Eye Center

Lancaster, California, United States

Colorado Retina Associates,PC

Golden, Colorado, United States

Outcomes

Primary Outcomes

Anterior Chamber Cell Grade at Week 8

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.

Time frame: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Data from ClinicalTrials.gov

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