A Safety and Efficacy Study of NS2 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.

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Key information

Conditions

Non-infectious Anterior Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Anterior

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hull Eye Center, Lancaster, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NS2

Drug

NS2 ophthalmic drops (0.5%)

Prednisolone acetate ophthalmic suspension (1%)

Drug

Other names: Pred Forte

Primary outcomes

Anterior Chamber Cell Grade at Week 8

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 2, 2015
Registry last updated: Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed