A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects

Persistent Corneal Epithelial Defect Clinical Trial

Official title: A Pilot Study of the Safety and Effectiveness of the EyeGate Ocular Bandage Gel, a 0.75% Crosslinked Hyaluronic Acid Applied Topically for the Improvement of Persistent Corneal Epithelial Defects (PED)

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of topical KIO-201 in patients with persistent corneal epithelial defects (PED). KIO-201 will be administered six (6) times per day while awake for 4 weeks.

The primary exploratory effectiveness outcome for this study is the percentage of patients achieving corneal healing as determined by corneal fluorescein staining and photos. The effectiveness endpoint will be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.

Clinical Trial Description

This is a prospective, exploratory study in which up to 10 patients (up to 20 eyes [minimum of 10 eyes]) diagnosed with Stage 1 and Stage 2 PED (as defined by fluorescein staining of the cornea and refractory to one or more conventional non-surgical treatments of at least 2 weeks) will receive KIO-201 with a dosing regimen of six (6) times per day over 4 weeks.

Both eyes are to be included if both eyes meet inclusion criteria and both eyes will be treated with KIO-201.

Patients will followed for a 4 week study. ;

Related Conditions & MeSH terms

• Persistent Corneal Epithelial Defect

• NCT number: NCT05436288
• Study type: Interventional
• Source: Kiora Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2022
• Completion date: January 22, 2023