This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.
Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
Subject must provide written informed consent (or assent)
Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test
Have a known ocular infection that is deemed to be active requiring therapeutic intervention
Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
Parallel
lufepirsen high dose
DrugLufepirsen is an unmodified connexin43 antisense oligonucleotide.
Vehicle
DrugMatching vehicle without lufepirsen.
lufepirsen low dose
DrugLufepirsen is an unmodified connexin43 antisense oligonucleotide.
Achieve Corneal Re-epithelialization Including Durability (CRC)
The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).
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