Pain, Postoperative Clinical Trial
Official title:
Multi-Center, Double-Masked, Randomized, Placebo-Controlled Phase 2b Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Having Undergone Cataract Surgery With Implantation of a Posterior Chamber Intraocular Lens (IOL)
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.
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