ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects (NCT05066698) | Clinical Trial Compass
TerminatedPhase 2
ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects
Stopped: Sponsor undergoing financial hardships - no longer able to support trial; no safety concerns.
United States8 participantsStarted 2022-04-27
Plain-language summary
The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) at Screening and Baseline (Day 1) and must be measurable by slit lamp.
✓. 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
✕. Diabetic cohort only: enrollment will be limited to include up to 50% of subjects with diabetes, as indicated by HbA1c level \>6.5%. Subjects with a HbA1c level \>6.5% after closure of the diabetic cohort will be excluded.
✕. Subjects currently being treated with cenegermin or other rhNGF in the study eye.
✕. Subjects currently using topical antibiotic eye drops in the study eye. Subjects on current antibiotic therapy must be willing to switch to study-provided moxifloxacin.
✕. 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.