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 Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis

Trial Profile

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 Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis

Completed
Phase of Trial: Phase III

Latest Information Update: 04 May 2015

At a glance

  • Drugs Dexamethasone (Primary) ; Prednisolone acetate
  • Indications Uveitis
  • Focus Registrational; Therapeutic Use
  • Sponsors EyeGate Pharma
  • Most Recent Events

    • 04 May 2015 The US FDA provided guidance that if a confirmatory phase III trial of EGP-437 in anterior uveitis ((see trial profile 700255415) meets non-inferiority criteria, data from that trial along with data from this trial will be sufficient to support a New Drug Application (NDA) filing, according to an EyeGate Pharma media release.
    • 14 May 2014 New trial record
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