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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
193
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
Proportion of patients with with ACC count of zero at Day 14
Proportion of patients 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 7
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 28
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 56
The 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
Mean change from baseline in ACC count and score at Day 7
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 14
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 28
Mean change from baseline in ACC count and score at Day 28
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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 56
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
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 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 14
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 28
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 56
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
Time to anterior chamber cell count and score of zero
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