A clear path for PCED starts here

ABOUT PCED

Persistent corneal epithelial defect (PCED) is a rare condition in which the corneal epithelium fails to heal within the normal 10- to 14-day timeframe, despite standard interventions such as lubrication, bandage contact lenses, or other protective measures.

PCED often overlaps with—or results from—conditions like Sjögren’s syndrome, limbal stem cell deficiency, dry eye disease, neurotrophic keratitis, and other ocular surface disorders. This can make clinical differentiation challenging. The defining feature of PCED, however, is a persistent, nonhealing epithelial defect lasting more than 2 weeks.

If you have a patient with a persistent epithelial defect that is unresponsive to conventional therapy, consider PCED. Additional symptoms may include:

• Eye pain
• Blurred or fluctuating vision
• Swelling of the eye
• Photophobia

Patients with these symptoms may be eligible for a new clinical trial.

ABOUT THE TRIAL

This randomized, multicenter, double-masked, vehicle-controlled study is evaluating the safety and efficacy of an ophthalmic gel in pediatric and adult patients aged 2 years and older with PCED.

The study is actively enrolling participants for once-weekly treatment and includes:

• A screening period
• A treatment period (up to 8 weeks)
• A follow-up period (4 weeks)
• An open-label treatment period (up to 8 weeks)

• 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 with 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 (eg, 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
• Potential side effects

  Potential side effects previously reported may include eye pain, headache, symblepharon, corneal epithelium defect, and hypopyon.

Interested in becoming a trial investigator?

Contact Clinical [at] pceds.com