Corneal Ulcer, Keratitis, Ulcerative
Conditions
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.
Interventions
BIOLOGICALSygeLIX-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.
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Improvement of visual acuity | 7 days, 15 days, 40 days | Visual acuity evaluated on Monoyer chart |
Countries
France
Outcome results
None listed