Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Condition: Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 3

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 description: 
      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.
    

Intervention name(s): 40 mg/mL Dexamethasone phosphate ophthalmic solution; Prednisolone Acetate (1%) Eyedrops; 100 mM sodium citrate buffer solution; Placebo Eyedrops
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis); Prednisolone acetate (1%) eyedrops; Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution; Placebo Eyedrops
Other intervention name(s): Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution
Intervention MeSH terms: Benzalkonium Compounds; Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Citric Acid; Sodium Citrate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iontophoresis; Non-Infectious Anterior Segment Uveitis; Ophthalmology