NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries

Summary

This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.

Timeline

Start

2020-06-30

Primary completion

2022-02-07

Completion

2022-02-07

Outcome

Outcome not reported

Stopped: “The study was stopped early (n=35) enabling the data to guide design of the subsequent clinical study.”

Drugs

Indications