A Phase 1 interventional study of SygeLIX-Coll-T in Keratitis, Ulcerative and Corneal Ulcer, sponsored by TBF Genie Tissulaire. Completed at 6 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by TBF Genie Tissulaire · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
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
Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.
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
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
Plan to share: No
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire