Phase 2 N=45 Randomized Triple-blind Treatment

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

Non-infectious Anterior Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT02406209 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Anterior Chamber Cell Grade at Week 8 — -0.7; -0.9; -0.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NS2 (Drug); Prednisolone acetate ophthalmic suspension (1%) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aldeyra Therapeutics, Inc.
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Anterior Chamber Cell Grade at Week 8	-0.7; -0.9; -0.5	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02406209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.