Evaluating NEXAGON® for treating persistent corneal epithelial defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Glaukos Investigative Site
  Dothan, Alabama, United States Recruiting
• Glaukos Investigative Site
  Petaluma, California, United States Recruiting
• Glaukos Investigative Site
  Torrance, California, United States Recruiting
• Glaukos Investigative Site
  Colorado Springs, Colorado, United States Recruiting
• Glaukos Investigative Site
  Grand Junction, Colorado, United States Recruiting
• Glaukos Investigative Site
  Bradenton, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: ClinicalResearch@Glaukos.com
• Phone: 949-739-8749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TP-06 for Persistent Corneal Epithelial Defects: see if healing improves

  This study tests TP-06 2.0% versus a vehicle to see if it helps adult patients with persistent corneal epithelial defects heal better.

  Recruiting at 6 sites Phase 2 Tarsus Pharmaceuticals, Inc. · Scottsdale, Arizona and 13 other locations · NCT07886268

• Topical insulin drops vs amniotic membrane graft for persistent corneal epithelial defects

  We will test whether topical insulin eye drops or an amniotic membrane graft better helps heal persistent corneal epithelial defects that have not improved with standard treatment.

  Recruiting Phase 4 Al-Shifa Trust Eye Hospital · Rawalpindi, Punjab Province · NCT07561398

• Efficacy and safety of cenegermin eye drops for persistent corneal epithelial defects

  This study tests whether cenegermin eye drops can heal persistent corneal epithelial defects better than a vehicle in adults with PCED.

  Recruiting at 51 sites Phase 3 Dompé Farmaceutici S.p.A · Huntington Beach, California and 76 other locations · NCT07519902

• Topical mesenchymal stem cell secretions for persistent corneal epithelial defects

  This trial will test whether eye drops made from bone-marrow mesenchymal stem cell secretions can help adults whose corneal epithelial defects have not healed with standard treatments.

  Recruiting Phase 2 University of Illinois Chicago · Chicago, Illinois · NCT06919081

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.