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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis

Conditions
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Non-Infectious Anterior Uveitis

Intervention / Treatment
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* Drug: 8% Dexamethasone Sodium Phosphate - Visulex
* Drug: 15% Dexamethasone Sodium Phosphate - Visulex
* Drug: Prednisolone Acetate (1%) Eye Drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8% DSP-Visulex<br>8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye. | Drug: 8% Dexamethasone Sodium Phosphate - Visulex<br> <br> * Other names: 8% DSP- Visulex;|
| Experimental: 15% DSP-Visulex<br>15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye. | Drug: 15% Dexamethasone Sodium Phosphate - Visulex<br> <br> * Other names: 8% DSP- Visulex;|
| Active Comparator: Pred Forte<br>Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye. | Drug: Prednisolone Acetate (1%) Eye Drops<br> <br> * Other names: Pred Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with anterior chamber cell ACC grade of zero |  | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-emergent adverse events |  | 29 days | 
| Proportion of patients with no uveitis symptoms |  | 29 days | 
| Proportion of patients with improvement in visual acuity | Change in ETDRS letter score | 29 days | 
| Change from baseline in anterior chamber cell (ACC) grade |  | Day 8 | 
| Change from baseline in anterior chamber cell (ACC) grade |  | Day 15 | 
| Change from baseline in anterior chamber cell (ACC) grade |  | Day 29 | 
| Proportion of patients with anterior chamber cell ACC grade of zero |  | Day 8 | 
| Proportion of patients with anterior chamber cell ACC grade of zero |  | Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uveitis, acute uveitis, anterior uveitis, dexamethasone sodium phosphate, non-infectious uveitis, DSP-Visulex, Aciont