Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

Aciont Inc

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Infectious Anterior Uveitis

Treatments: Drug: 8% Dexamethasone Sodium Phosphate - Visulex; Drug: Prednisolone Acetate (1%) Eye Drops; Drug: 15% Dexamethasone Sodium Phosphate - Visulex

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02309385

DSPV-201

R44EY014772 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.

Full description

This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-infectious anterior uveitis

Exclusion criteria

• lntraocular pressure > 25mm Hg OU.
• Previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to Visit 1.
• Historical or active intermediate or posterior uveitis in affected eye(s).
• Clear systemic causes of uveitis that may require or have required systemic treatment
• Uveitis suspected to have resulted from recent surgery or trauma.
• Use of ocular medication of any kind in affected eye(s) more than 2 days prior to Visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs.
• Current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). Current stable use is allowed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 3 patient groups

8% DSP-Visulex

Experimental group

Description:

8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Treatment:

Drug: 8% Dexamethasone Sodium Phosphate - Visulex

15% DSP-Visulex

Experimental group

Description:

15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Treatment:

Drug: 15% Dexamethasone Sodium Phosphate - Visulex

Pred Forte

Active Comparator group

Description:

Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.

Treatment:

Drug: Prednisolone Acetate (1%) Eye Drops