CompletedPhase 2

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

United States45 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Anterior Chamber Cell Grade at Week 8

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

Trial details

NCT IDNCT02406209

SponsorAldeyra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2023-02-27

View on ClinicalTrials.gov More Non-infectious Anterior Uveitis trials