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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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-in

Brief 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 Summary: 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.
Sponsor: Aciont Inc

Current Primary Outcome: Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 15 ]

Original Primary Outcome: Proportion of patients with anterior chamber cell ACC count of zero [ Time Frame: Day 15 ]

Current Secondary Outcome:

  • Number of patients with treatment-emergent adverse events [ Time Frame: 29 days ]
  • Proportion of patients with no uveitis symptoms [ Time Frame: 29 days ]
  • Proportion of patients with improvement in visual acuity [ Time Frame: 29 days ]
    Change in ETDRS letter score
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 8 ]
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 15 ]
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 29 ]
  • Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 8 ]
  • Proportion of patients with anterior chamber cell ACC grade of zero [ Time Frame: Day 29 ]


Original Secondary Outcome:

  • Number of patients with treatment-emergent adverse events [ Time Frame: 29 days ]
  • Proportion of patients with no uveitis symptoms [ Time Frame: 29 days ]
  • Proportion of patients with improvement in visual acuity [ Time Frame: 29 days ]
    Change in ETDRS letter score
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 8 ]
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 15 ]
  • Change from baseline in anterior chamber cell (ACC) grade [ Time Frame: Day 29 ]
  • Proportion of patients with anterior chamber cell ACC count of zero [ Time Frame: Day 8 ]
  • Proportion of patients with anterior chamber cell ACC count of zero [ Time Frame: Day 29 ]


Information By: Aciont Inc

Dates:
Date Received: December 1, 2014
Date Started: October 2014
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017