NCT05066698

ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Corneal Epithelial Defect

Interventions

Type	Name	Description
BIOLOGICAL	ST266	Topical ocular application: one drop four times a day for eight weeks
OTHER	0.67% Sodium Chloride Ophthalmic Solution	Topical ocular application: one drop four times a day for eight weeks
BIOLOGICAL	Open-label ST266	Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks

Timeline

• Start date: 2022-04-27
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2021-10-04
• Last updated: 2022-10-25

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study