Corneal Epithelial Defect

Actively Recruiting // Clinical Trials // Cornea // Persistent Corneal Epithelial Defect // Sarah Nehls // Aug 02 2022

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects

  • Sponsor: Noveome Biotherapeutics
  • Principal Investigator: Sarah Nehls, MD
  • ┬áStudy Coordinator: Kris Dietzman

Study Objective:

To determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED).

Study Design:

Subjects will be treated in a double-blind fashion with ST266 eye drops or placebo eye drops, administered 4 times a day for 8 weeks. At the week 8 visit, non-healers will enter the open-label treatment extension, receiving ST266 eye drops administered 4 times a day for 8 weeks. All subjects will undergo a 12-week Post Treatment Follow-Up period following end of treatment.

Inclusion Criteria:

  • Male and non-pregnant/non-breastfeeding female subjects aged 18 years and older.
  • Subjects with a PED present for at least seven (7) days at the time of Screening.
  • The defect must be at least 1.0 mm (longest linear measurement)
  • In the Investigator’s opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
  • The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.

Exclusion Criteria:

  • Subjects currently being treated with cenegermin or other rhNGF in the study eye.
  • Subjects currently taking topical steroids or corticosteroid-containing eye drops or ointment in the study eye. Subjects currently taking systemic corticosteroids with a dose of >10mg/day prednisone or equivalent.
  • Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
  • Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or lifitegrast) in the study eye.
  • Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
  • Subjects who need to use contact lenses for refractive correction during the study.
  • Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
  • Subjects currently taking antiviral medications for an active infection in the study eye.
  • History of ocular surgery (including laser or refractive surgery) in the study eye within 1 month prior to study screening or, in the opinion of the Investigator, there are persistent post-surgical complications that would impact the study data.
  • Subjects who have a history of AIDS or HIV.
  • Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed.
  • Subjects with bullous keratopathy in the study eye.
  • Subjects with corneal perforation or impending corneal perforation in the study eye.
  • Subjects with uncontrolled glaucoma.
  • Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren’s ulceration.
  • Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
  • Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.

Contact Kris Dietzman with questions, 608-263-9035

For more information about this study, visit clinicaltrials.gov:

clinicaltrials.gov