Loading clinical trials...

A Study of the KIO-201 (Ocular Bandage Gel) for Improving Persistent Corneal Epithelial Defects | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT05436288•Kiora Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•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.
•Prior surgical procedure(s) for the treatment of PED in the affected eye(s).
•Patients with lid abnormalities.
•Corneal disease that may affect outcomes.
•Stage 3 PED.

Locations (1)

Instituto de Oftalmología Fundación Conde de Valenciana

Mexico City, Chimalpopoca 14 Colonia Obrera, Mexico

Key Dates

Start Date

July 1, 2022

Primary Completion Date

December 22, 2022

Completion Date

January 22, 2023

Last Updated

April 3, 2024

Enrollment

ACTUAL participants

Conditions

Persistent Corneal Epithelial Defect

Interventions

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

DRUG

Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

NCT06919081

Persistent Corneal Epithelial DefectCorneal Epithelial Disorders

View study

RECRUITINGPHASE2

A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

NCT05966493

Persistent Corneal Epithelial Defect

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

Platelet Rich Plasma in Corneal Surface Diseases

Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers

Autologous Platelet Lysate in Corneal Epithelial Defects