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)

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.

Study Overview

• Status: Completed
• Conditions: Persistent Corneal Epithelial Defect
• Intervention / Treatment: Drug: KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eric Daniels, M.D., MBA; Phone Number: 858-353-0469; Email: edaniels@kiorapharma.com

Study Locations

• Mexico
  • Chimalpopoca 14 Colonia Obrera
    • Mexico City, Chimalpopoca 14 Colonia Obrera, Mexico, 06800
      • Instituto de Oftalmología Fundación Conde de Valenciana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm active; KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S), up to 6 times a day for 4 weeks.	Drug: KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Achieving Corneal Healing (<0.5 mm2 Lesion Size) of the Persistent Corneal Epithelial Defect at 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.	4 weeks

Collaborators and Investigators

• Sponsor: Kiora Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Enrique Graue, M.D., Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): January 22, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: OBG PED-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes