NCT02309385

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Aciont Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Non-Infectious Anterior Uveitis

Interventions

Type	Name	Description
DRUG	8% Dexamethasone Sodium Phosphate - Visulex
DRUG	15% Dexamethasone Sodium Phosphate - Visulex
DRUG	Prednisolone Acetate (1%) Eye Drops

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-03-03
• Completion: 2017-03-03
• First posted: 2014-12-05
• Last updated: 2017-04-27

Locations

6 sites across 1 country: United States