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

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.

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Key information

Conditions

Persistent Corneal Epithelial Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Oftalmología Fundación Conde de Valenciana

Mexico City, Chimalpopoca 14 Colonia Obrera, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

KIO-201 is a stand-alone drug therapy that acts as a barrier that minimizes mechanical lid friction and mechanically protects the ocular surface thereby reducing repeat injury and providing an environment that enables the body to repair the ocular surface whether the corneal epithelial defects are large or small.

Primary outcomes

Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 4 Weeks

Time frame: 4 weeks

Determined by corneal fluorescein staining and the effectiveness endpoint will also be evaluated by a reader using digital photography of fluorescein stained slit lamp photos and image analysis.

Sponsors and collaborators

Lead sponsor

Kiora Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jun 29, 2022
Registry last updated: Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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