Phase 2b trial evaluating the safety and efficacy of EGP-437, versus placebo using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a monofocal posterior chamber intraocular lens (IOL).
This will be a Phase 2b, double-masked, multi-site study, in which a total of up to 100 eyes of up to 100 subject will be enrolled at up to 8 clinical sites in the United States. The study has 2 different treatment arms consisting of the following iontophoresis treatment regimen: Treatment Arm 1, up to 50 subjects will receive the following study treatment: 40 mg/ml dexamethasone phosphate solution delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination. Treatment Arm 2, up to 50 subjects will receive the following study treatment: 100 mM sodium citrate buffer solution (placebo) delivered by iontophoresis treatment consisting of 4.5 mA-min at 3.0 mA on Day 0 (immediately following cataract surgery), Day 1 (24 hours' post-cataract surgery), Day 4, and a potential Day 7 treatment that will be administered for subjects who have ≥11 AC cells per high-power field on slit lamp examination. Subjects will come in for 6 visits over 28 days. The primary efficacy endpoint (PEP) will evaluate 1) the proportion of subjects with an AC cell count of zero on Day 7 and 2) the proportion of subjects with a pain score of zero on Day 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
Ocular iontophoretic delivery of a steroid
Ocular iontophoretic delivery of a placebo
Site 901
Jacksonville, Florida, United States
AC cell count = 0
The proportion of subjects with an AC cell count of zero on Day 7
Time frame: 7 days' following first study treatment
Pain score = 0
The proportion of subjects with a pain score of zero on Day 1
Time frame: 1 day post-surgery and following first study treatment
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