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

Completed · Phase 1/Phase 2

Conditions studied: Non-Infectious Anterior Uveitis

In brief

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.

Key facts

Study ID

NCT02309385

Run by

Aciont Inc

People needed

44

Starts

2014-10-01

Expected to finish

2017-03-03

Last updated by the study team

2017-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-infectious anterior uveitis

You may not qualify if…

• 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.

Where it is running

• Massachusetts Eye Research and Surgery Institution (MERSI) — Cambridge, Massachusetts, United States
• Charlotte Eye, Ear, Nose, and Throat Associates — Charlotte, North Carolina, United States
• Bergstrom Eye Research — Fargo, North Dakota, United States
• B-Berger and Associates — Austin, Texas, United States
• Retina and Uveitis Consultants of Texas — San Antonio, Texas, United States
• Moran Eye Center, University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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