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

Corneal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200000
• Other study ID #: SygeLIX-C-TBF1
• Secondary ID: 2019-A00866-51
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2020
• Est. completion date: June 20, 2023

Study information

• Verified date: February 2024
• Source: TBF Genie Tissulaire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Ulcer
• Keratitis

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Michallon, CHU de Grenoble	La Tronche
France	Hôpital Gui de Chauliac, CHU de Montpellier	Montpellier
France	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Paris
France	Hôpital Fondation Adolphe de Rothschild	Paris
France	Hôpital Charles-Nicolle, CHU de Rouen	Rouen
France	Hôpital Nord, CHU de Saint-Etienne	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Improvement of visual acuity	Visual acuity evaluated on Monoyer chart	7 days, 15 days, 40 days