Completed

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)

What is being tested

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S)

Drug

Who is being recruted

Over 18 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: July 2022

See protocol details

Summary

Principal SponsorKiora Pharmaceuticals, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA 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)

NCT05436288

Principal SponsorKiora Pharmaceuticals, Inc.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Patients 18 years of age or older.

Patients with persistent corneal epithelial defects (PED) (Stage 1 and Stage 2 PED).

Patients with PED in one or both eyes, at least one eye meeting all study criteria.

Have PED of at least 2 weeks' duration refractory to one or more conventional non-surgical treatments for Stage 1 and Stage 2 PED (i.e., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops).

8 exclusion criteria prevent from participating

Have any active ocular infection (bacterial, viral, fungal or protozoal) in the affected eye(s).

Schirmer's test without anesthesia ≤ 3 mm/ 5 minutes in the affected eye(s).

Patients who have received amniotic membrane transplantation and have not healed.

Patients treated with a bandage contact lens but have not healed.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Instituto de Oftalmología Fundación Conde de Valenciana

Mexico City, MexicoOpen Instituto de Oftalmología Fundación Conde de Valenciana in Google Maps

CompletedOne Study Center