A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects W… (NCT05966493) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
United States84 participantsStarted 2023-08-17
Plain-language summary
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.
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
âś“. 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
âś“. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
âś“. Subject must provide written informed consent (or assent)
âś“. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test
Exclusion criteria
âś•. Have a known ocular infection that is deemed to be active requiring therapeutic intervention
âś•. 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
âś•. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
âś•. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
âś•. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
âś•. Have any other ocular disease requiring topical ocular medication in the affected eye
âś•. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
What they're measuring
1
Achieve Corneal Re-epithelialization Including Durability (CRC)
Timeframe: End of Study: 28 Days after achieving re-epithelialization