Clinical Trial: Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

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

Official Title: A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solu

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Detailed Summary:

Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it is the most common form of uveitis and accounts for approximately 75% of cases.

In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437 treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without requiring additional treatment; produced low short-term systemic exposure to dexamethasone and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8 mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid mediated effects were observed.

The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.


Sponsor: Eyegate Pharmaceuticals, Inc.

Current Primary Outcome: Proportion of patients with with ACC count of zero at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]

Proportion of patients with ACC count of zero at Day 14


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients with ACC count of zero at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 7
  • Proportion of patients with ACC count of zero at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 28
  • Proportion of patients with ACC count of zero at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of patients with ACC count of zero at Day 56
  • Mean change from baseline in ACC count and score at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 7
  • Mean change from baseline in ACC count and score at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 14
  • Mean change from baseline in ACC count and score at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 28
  • Mean change from baseline in ACC count and score at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 56
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
  • Time to anterior chamber cell count and score of zero [ Time Frame: Up to 56 days (plus or minus seven days) following the first study treatment ]
    Time to anterior chamber cell count and score of zero


Original Secondary Outcome:

  • Proportion of patients with ACC count of zero at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 7
  • Proportion of patients with ACC count of zero at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of patients with ACC count of zero at Day 28
  • Proportion of patients with ACC count of zero at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of patients with ACC count of zero at Day 56
  • Mean change from baseline in ACC count and score at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 7
  • Mean change from baseline in ACC count and score at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 14
  • Mean change from baseline in ACC count and score at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 28
  • Mean change from baseline in ACC count and score at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    Mean change from baseline in ACC count and score at Day 56
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7 [ Time Frame: At Day 7 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14 [ Time Frame: At Day 14 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
  • Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28 [ Time Frame: At Day 28 (plus or minus two days) following the first study treatment ]
    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
  • The proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56 [ Time Frame: At Day 56 (plus or minus seven days) following the first study treatment ]
    The proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
  • Time to anterior chamber cell count and score of zero [ Time Frame: Up to 56 days (plus or minus seven days) following the first study treatment ]
    Time to anterior chamber cell count and score of zero


Information By: Eyegate Pharmaceuticals, Inc.

Dates:
Date Received: January 4, 2012
Date Started: December 2011
Date Completion:
Last Updated: March 28, 2013
Last Verified: March 2013