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

Sponsor

Kiora Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05436288

Collaborator

(none)

Enrollment

Location

Arm

5.7

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Corneal Epithelial Defect	Drug: KIO-201, a Crosslinked Thiolated Carboxymethyl Hyaluronic Acid 0.75% (CMHA-S)	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Nov 22, 2022

Anticipated Study Completion Date :

Dec 22, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of patients achieving corneal healing of the PED [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.
Time to complete corneal healing [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.
Investigator global evaluation of effectiveness at Week 4 [4 weeks]
Questionnaire completed by Principal Investigator

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto de Oftalmología Fundación Conde de Valenciana	Mexico City	Chimalpopoca 14 Colonia Obrera	Mexico	06800

Sponsors and Collaborators

Kiora Pharmaceuticals, Inc.

Investigators

Principal Investigator: Enrique Graue, M.D., Instituto de Oftalmología Fundación Conde de Valenciana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kiora Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT05436288

Other Study ID Numbers:

OBG PED-001

First Posted:

Jun 29, 2022

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Hyaluronic Acid

Study Results

No Results Posted as of Jul 8, 2022