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



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:March 2016
Contact:Kongnara Papangkorn, PhD
Email:kpapangkorn@aciont.com
Phone:8015819981

Use our guide to learn which trials are right for you!

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

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.

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.

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.
We found this trial at
6
sites
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Cambridge, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Fargo, North Dakota 58103
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials