Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
- Conditions
- Corneal UlcerKeratitis, Ulcerative
- Interventions
- Biological: SygeLIX-Coll-T
- Registration Number
- NCT05200000
- Lead Sponsor
- TBF Genie Tissulaire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SygeLIX-Coll-T 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Improvement of visual acuity 7 days, 15 days, 40 days Visual acuity evaluated on Monoyer chart
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)
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
Trial Locations
- Locations (6)
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
馃嚝馃嚪Paris, France
H么pital Michallon, CHU de Grenoble
馃嚝馃嚪La Tronche, France
H么pital Gui de Chauliac, CHU de Montpellier
馃嚝馃嚪Montpellier, France
H么pital Charles-Nicolle, CHU de Rouen
馃嚝馃嚪Rouen, France
H么pital Fondation Adolphe de Rothschild
馃嚝馃嚪Paris, France
H么pital Nord, CHU de Saint-Etienne
馃嚝馃嚪Saint-Priest-en-Jarez, France