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

Phase 1CompletedNCT05200000

TBF Genie Tissulaire20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keratitis, Ulcerative Corneal Ulcer

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

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

Time frame: Through study completion - average of 40 days

Secondary Outcomes

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)

Time frame: 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

Time frame: 7 days, 15 days, 40 days

Improvement of visual acuity

Visual acuity evaluated on Monoyer chart

Time frame: 7 days, 15 days, 40 days

Data from ClinicalTrials.gov

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