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.
63 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 45 interventional studies indexed under Corneal Ulcer.
Browse Corneal Ulcer studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jun 2023, 41 months.
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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