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
Study Coordinator: Kris Dietzman
To determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED).
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.
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.
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: