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Evaluating NEXAGON® for treating persistent corneal epithelial defects

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)

Phase 2 Interventional Glaukos Corporation · NCT05966493

This study is testing if NEXAGON® eye gel can help people with stubborn corneal problems that haven't improved with regular treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment84 (estimated)
Ages2 Years and up
SexAll
SponsorGlaukos Corporation Industry-sponsored
Locations28 sites (Dothan, Alabama and 27 other locations)
Trial IDNCT05966493 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) in patients with persistent corneal epithelial defects (PCED). It is a randomized, multicenter, double-masked, vehicle-controlled trial that will enroll subjects who have not responded to conventional treatments. Participants will undergo a screening period, followed by an 8-week treatment period, and a 4-week follow-up. Those who do not achieve or maintain re-epithelialization may enter an additional open-label treatment phase.

Who should consider this trial

Good fit: Ideal candidates are individuals with PCED lasting at least 2 weeks who have not improved with standard non-surgical treatments.

Not a fit: Patients with active ocular infections or corneal defects due to infectious causes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from persistent corneal epithelial defects.

How similar studies have performed: Other studies have shown promise in treating corneal defects with similar approaches, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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
2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
3. Subject must provide written informed consent (or assent)
4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion Criteria:

1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention
2. 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
3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
6. Have any other ocular disease requiring topical ocular medication in the affected eye
7. 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
8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
10. Use of the medications presented in the protocol that are prohibited in the study.

Where this trial is running

Dothan, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Persistent Corneal Epithelial DefectPCEDCorneal DefectPED
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.