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Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis

Primary Purpose

Keratitis, Ulcerative, Corneal Ulcer

Status

Recruiting

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

SygeLIX-Coll-T

About this trial

This is an interventional treatment trial for Keratitis, Ulcerative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women between 18 and 70 years old.
Persistent corneal ulceration.
Resistance to medical treatment for more than one month or recurrence after medical treatment.
Patient who underwent a wash-out period of 15 days with no use of eye drops with preservative.
Patient with dry eye treatments that can be kept: tear substitutes, cyclosporine.
Informed and consenting patient.
Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:

Patient with active infectious or traumatic keratitis such as burns.
Patient with herpetic keratitis.
Patient currently wearing contact lens, including scleral lenses concomitant with the treatment.
Patient currently treated with NSAIDs in eye drops or any eye drops containing preservatives.
Patient treated with antibiotic, anti-viral or anti-parasitic eye drops; with autologous or allogeneic serum; with platelet derivatives; with eye drops claiming healing properties; with eye drops containing growth factors, hyaluronic acid or trehalose.
Patient with hypersensitivity to fluorescein.
Patient with identified causes for keratitis for which discontinuation of medical treatment is beneficial.
Monophthalmic patients.
Persons deprived of liberty by a judicial or administrative decision.
Adults who are subject to a legal protection measure or who are unable to express their consent.
Pregnant woman.

Sites / Locations

Hôpital Michallon, CHU de GrenobleRecruiting
Hôpital Gui de Chauliac, CHU de MontpellierRecruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsRecruiting
Hôpital Fondation Adolphe de RothschildRecruiting
Hôpital Charles-Nicolle, CHU de RouenRecruiting
Hôpital Nord, CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SygeLIX-Coll-T

Arm Description

Extract of umbilical cord lining constituted of Wharton's jelly put in suspension in microvials. Instillation by the patient in the sick eye of 1 drop 5 times a days (morning, noon, afternoon, evening and bedtime) for 40 days.

Outcomes

Primary Outcome Measures

Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect

Inflammatory signs evaluated using a composite score on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye

Secondary Outcome Measures

Re-epithelialization of the cornea

Epithelialization assessed by the Oxford score after fluorescein instillation in the eye (0: no corneal staining to 5: severe corneal staining)

Improvement of dry eyes signs and symptoms

Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire

Improvement of visual acuity

Visual acuity evaluated on Monoyer chart

Full Information

NCT ID

NCT05200000

First Posted

January 5, 2022

Last Updated

April 28, 2023

Sponsor

TBF Genie Tissulaire

1. Study Identification

Unique Protocol Identification Number

NCT05200000

Brief Title

Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis

Official Title

Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 8, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TBF Genie Tissulaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this open, non-comparative, multicenter trial is to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratitis, Ulcerative, Corneal Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SygeLIX-Coll-T

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

SygeLIX-Coll-T

Intervention Description

Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.

Primary Outcome Measure Information:

Title

Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect

Description

Time Frame

Through study completion - average of 40 days

Secondary Outcome Measure Information:

Title

Re-epithelialization of the cornea

Description

Epithelialization assessed by the Oxford score after fluorescein instillation in the eye (0: no corneal staining to 5: severe corneal staining)

Time Frame

7 days, 15 days, 40 days

Title

Improvement of dry eyes signs and symptoms

Description

Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire

Time Frame

7 days, 15 days, 40 days

Title

Improvement of visual acuity

Description

Visual acuity evaluated on Monoyer chart

Time Frame

7 days, 15 days, 40 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women between 18 and 70 years old. Persistent corneal ulceration. Resistance to medical treatment for more than one month or recurrence after medical treatment. Patient who underwent a wash-out period of 15 days with no use of eye drops with preservative. Patient with dry eye treatments that can be kept: tear substitutes, cyclosporine. Informed and consenting patient. Patient affiliated to a social security system or beneficiary of such a system. Exclusion Criteria: Patient with active infectious or traumatic keratitis such as burns. Patient with herpetic keratitis. Patient currently wearing contact lens, including scleral lenses concomitant with the treatment. Patient currently treated with NSAIDs in eye drops or any eye drops containing preservatives. Patient treated with antibiotic, anti-viral or anti-parasitic eye drops; with autologous or allogeneic serum; with platelet derivatives; with eye drops claiming healing properties; with eye drops containing growth factors, hyaluronic acid or trehalose. Patient with hypersensitivity to fluorescein. Patient with identified causes for keratitis for which discontinuation of medical treatment is beneficial. Monophthalmic patients. Persons deprived of liberty by a judicial or administrative decision. Adults who are subject to a legal protection measure or who are unable to express their consent. Pregnant woman.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laurence BARNOUIN, MD

Phone

4 72 68 69 09

Ext

+33

laurence.barnouin@tbf-lab.com

First Name & Middle Initial & Last Name or Official Title & Degree

Justine BOSC, MSc

Phone

4 72 68 69 11

Ext

+33

justine.bosc@tbf-lab.com

Facility Information:

Facility Name

Hôpital Michallon, CHU de Grenoble

City

La Tronche

ZIP/Postal Code

38700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diane BERNHEIM, MD

dberheim@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Diane BERNHEIM, MD

Facility Name

Hôpital Gui de Chauliac, CHU de Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent DAIEN, Professor

v-daien@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Vincent DAIEN, Professor

Facility Name

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

City

Paris

ZIP/Postal Code

75012

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christophe BAUDOUIN, Professor

cbaudouin@15-20.fr

First Name & Middle Initial & Last Name & Degree

Christophe BAUDOUIN, Professor

Facility Name

Hôpital Fondation Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric GABISON, Professor

egabison@for.paris

First Name & Middle Initial & Last Name & Degree

Eric GABISON, Professor

First Name & Middle Initial & Last Name & Degree

Anna GEMAHLING, MD

Facility Name

Hôpital Charles-Nicolle, CHU de Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julie GUEUDRY MOUILHADE, Professor

julie.gueudry@chu-rouen.fr

First Name & Middle Initial & Last Name & Degree

Julie GUEUDRY MOUILHADE, Professor

Facility Name

Hôpital Nord, CHU de Saint-Etienne

City

Saint-Priest-en-Jarez

ZIP/Postal Code

42270

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Caroline TRONE, MD

mariecarolinetrone@gmail.com

First Name & Middle Initial & Last Name & Degree

Philippe GAIN, Professor

First Name & Middle Initial & Last Name & Degree

Marie-Caroline TRONE, MD

First Name & Middle Initial & Last Name & Degree

Emera CHHUY, MD

First Name & Middle Initial & Last Name & Degree

Lise LANFANT, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis

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