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

Sponsor
TBF Genie Tissulaire (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05200000
Collaborator
(none)
15
2
1
35.8
7.5
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: SygeLIX-Coll-T
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
Actual Study Start Date :
Jan 8, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect [Through study completion - average of 40 days]

    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

  1. Re-epithelialization of the cornea [7 days, 15 days, 40 days]

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

  2. Improvement of dry eyes signs and symptoms [7 days, 15 days, 40 days]

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

  3. Improvement of visual acuity [7 days, 15 days, 40 days]

    Visual acuity evaluated on Monoyer chart

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts Paris France 75012
2 CHU de Saint-Etienne Hôpital Nord Saint-Priest-en-Jarez France 42270

Sponsors and Collaborators

  • TBF Genie Tissulaire

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TBF Genie Tissulaire
ClinicalTrials.gov Identifier:
NCT05200000
Other Study ID Numbers:
  • SygeLIX-C-TBF1
  • 2019-A00866-51
First Posted:
Jan 20, 2022
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2022