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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2

Conditions: Non-infectious Anterior Uveitis

Treatments: Drug: NS2; Drug: Prednisolone acetate ophthalmic suspension (1%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406209

NS2-02

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

NS2

Experimental group

Description:

NS2 ophthalmic drops (0.5%) in the affected eye

Treatment:

Drug: NS2

NS2 and Pred Forte

Experimental group

Description:

NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye

Treatment:

Drug: Prednisolone acetate ophthalmic suspension (1%)

Drug: NS2

Pred Forte

Active Comparator group

Description:

Prednisolone acetate ophthalmic suspension (1%) in the affected eye

Treatment:

Drug: Prednisolone acetate ophthalmic suspension (1%)