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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
Nexagon® (lufepirsen) is administered topically in the affected eye three (3) times over 28 days.
Vehicle is administered topically in the affected eye three (3) times over 28 days.
Open-label Nexagon® (lufepirsen) for participants who do not heal (re-epithelialize) at the end of the 28-day treatment phase.
Jules Stein Eye Institute
Los Angeles, California, United States
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Time frame: Up to 56 days.
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
Time frame: Up to 30 days after last application of intervention
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