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 States, Germany, Italy84 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 range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Have a known ocular infection that is deemed to be active requiring therapeutic intervention
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Achieve Corneal Re-epithelialization Including Durability (CRC)
Timeframe: End of Study: 28 Days after achieving re-epithelialization
. 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
. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
. Have any other ocular disease requiring topical ocular medication in the affected eye
. 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
. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)