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

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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Ulcer; Keratitis, Ulcerative
• Intervention / Treatment: Biological: SygeLIX-Coll-T

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • Hôpital MICHALLON, CHU de Grenoble
  • Montpellier, France, 34295
    • Hôpital Gui de Chauliac, CHU de Montpellier
  • Paris, France, 75012
    • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
  • Paris, France, 75019
    • Hopital Fondation Adolphe de Rothschild
  • Rouen, France, 76000
    • Hôpital Charles-Nicolle, CHU de Rouen
  • Saint-Priest-en-Jarez, France, 42270
    • Hôpital Nord, CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

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: SygeLIX-Coll-T; 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.	Biological: SygeLIX-Coll-T; Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion - average of 40 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	7 days, 15 days, 40 days
Improvement of dry eyes signs and symptoms	Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire	7 days, 15 days, 40 days
Improvement of visual acuity	Visual acuity evaluated on Monoyer chart	7 days, 15 days, 40 days

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Corneal Diseases; Eye Infections; Keratitis; Corneal Ulcer
• Other Study ID Numbers: SygeLIX-C-TBF1; 2019-A00866-51 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No