Overview

In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.

Eligibility

Inclusion Criteria:

• Age · Patients 18 years of age or older
• Ocular Health
  • Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment
  • No objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 14 days
  • Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)
  • If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.
• Study Procedures
  • Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

• Ocular Health
  • Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
  • History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.
  • Treatment with Oxervate in the study eye within 12 months of enrollment.
• Study Procedures
  • Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
  • Use of any investigational agent within 4 weeks of screening visit.
  • Participation in another clinical study at the same time as the present study.
  • Participants who are pregnant at the time of study enrollment.