NCT05200000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2020

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

January 5, 2022

Last Update Submit

February 19, 2024

Conditions

Keratitis, UlcerativeCorneal Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Re-epithelialization of the cornea

    7 days, 15 days, 40 days

  • Improvement of dry eyes signs and symptoms

    7 days, 15 days, 40 days

  • Improvement of visual acuity

    7 days, 15 days, 40 days

Study Arms (1)

SygeLIX-Coll-T

EXPERIMENTAL

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

Interventions

SygeLIX-Coll-TBIOLOGICAL

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

SygeLIX-Coll-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Michallon, CHU de Grenoble

La Tronche, 38700, France

Location

Hôpital Gui de Chauliac, CHU de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Charles-Nicolle, CHU de Rouen

Rouen, 76000, France

Location

Hôpital Nord, CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

January 8, 2020

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)