A Phase 2 interventional study of LV-Visio-AMTRIX in Keratitis, sponsored by TBF Genie Tissulaire. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Sutureless amniotic membrane supported by a biological ring.
Biological: LV-Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
Keratitis healing within 15 days after the beginning of the treatment
Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford \< grade 2
Time frame: 15 days
Stable or decreased score for inflammatory and clinical signs of the ocular surface
Composite score for inflammatory and clinical signs of the ocular surface 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: 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale
Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain
Time frame: 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days
Preservation of epithelialization
Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system
Time frame: 15 days, 30 days, 45 days
Change in eye dryness
Eye dryness evaluated by the Ocular Surface Disease Index (OSDI) (0-12 = normal; 13-22 = mild dry eye; 23-32 = moderate dry eye; \>33 = severe dry eye)
Time frame: 15 days, 30 days, 45 days
Ran from Jun 2020 to primary completion in Jan 2021, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
TBF Genie Tissulaire