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

Study Overview
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Brief Summary
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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.

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

Conditions
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Keratitis, Ulcerative, Corneal Ulcer

Intervention / Treatment
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* Biological: SygeLIX-Coll-T


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SygeLIX-Coll-T<br>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<br>* Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Improvement of visual acuity | Visual acuity evaluated on Monoyer chart | 7 days, 15 days, 40 days |