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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

Therapeutic Area Corneal Disorders
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender Any
Contact Karaghan Curran, Nancy Gee
617-636-1051, 617-636-5489
More Information


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.

Study Details

Inclusion Criteria

• Subjects with a PED present for greater than 7 days
• Subjects with PED greater than 1.00mm
• Cornea defect is result of injury, infection, disease, or surgery to eye

Exclusion Criteria

Currently being treated with cenegermin or other RHNGF in study eye; bullous keratopathy in study eye, require serum tears

Study Requirements

Up to 29 weeks: 1-week Washout/Screening Period; 8-week Randomized, Double-Blind Treatment; 8-week Open-Label ST266 Treatment Extension; 12 week Post Treatment Follow-Up