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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-infectious Anterior Uveitis

Intervention / Treatment
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* Drug: NS2
* Drug: Prednisolone acetate ophthalmic suspension (1%)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NS2<br>NS2 ophthalmic drops (0.5%) in the affected eye | Drug: NS2<br>* NS2 ophthalmic drops (0.5%)<br>|
| Experimental: NS2 and Pred Forte<br>NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye | Drug: NS2<br>* NS2 ophthalmic drops (0.5%)<br>Drug: Prednisolone acetate ophthalmic suspension (1%)<br> <br> * Other names: Pred Forte;|
| Active Comparator: Pred Forte<br>Prednisolone acetate ophthalmic suspension (1%) in the affected eye | Drug: Prednisolone acetate ophthalmic suspension (1%)<br> <br> * Other names: Pred Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell Grade at Week 8 | 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. | The efficacy assessment period was assessed at Week 8; baseline was Day 1. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NS2, Aldeyra, uveitis, acute uveitis, anterior uveitis, prednisolone acetate