Trial | NCT02309385  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea prednisone ...

  • Study Participants

    44
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.
Study Started
Oct 31
2014
Primary Completion
Mar 03
2017
Study Completion
Mar 03
2017
Last Update
Apr 27
2017

Drug 8% Dexamethasone Sodium Phosphate - Visulex

  • Other names: 8% DSP- Visulex

Drug 15% Dexamethasone Sodium Phosphate - Visulex

  • Other names: 8% DSP- Visulex

Drug Prednisolone Acetate (1%) Eye Drops

  • Other names: Pred Forte

8% DSP-Visulex Experimental

8% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

15% DSP-Visulex Experimental

15% dexamethasone sodium phosphate - Visulex (DSP- Visulex) and placebo eye drops in the affected eye.

Pred Forte Active Comparator

Prednisolone acetate (1%) eye drops and vehicle - Visulex in the affected eye.

Criteria 

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.
No Results Posted