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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.