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 |
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.
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.
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
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