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

Completed · Phase 2

Conditions studied: Non-infectious Anterior Uveitis

In brief

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.

Key facts

Study ID

NCT02406209

Run by

Aldeyra Therapeutics, Inc.

People needed

45

Starts

2015-03-01

Expected to finish

2016-04-01

Last updated by the study team

2023-03-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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