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

TBF Genie Tissulaire

Status and phase: Completed; Phase 1

Conditions: Keratitis, Ulcerative; Corneal Ulcer

Treatments: Biological: SygeLIX-Coll-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT05200000

2019-A00866-51 (Registry Identifier)

SygeLIX-C-TBF1

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SygeLIX-Coll-T

Experimental group

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.

Treatment:

Biological: SygeLIX-Coll-T