NCT03180255

Iontophoretic Delivery of EGP-437 in Patients Who Have Undergone Cataract Surgery

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Eyegate Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Cataract
• Anterior Chamber Inflammation
• Pain, Postoperative

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dexamethasone phosphate	Ocular iontophoretic delivery of a steroid
OTHER	Placebo	Ocular iontophoretic delivery of a placebo

Timeline

• Start date: 2017-07-26
• Primary completion: 2017-11-07
• Completion: 2017-11-27
• First posted: 2017-06-08
• Last updated: 2018-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study