Back to resultsUse of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
Primary Purpose
Keratitis
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LV-Visio-AMTRIX
Sponsored by
About this trial
This is an interventional treatment trial for Keratitis
Eligibility Criteria
Inclusion Criteria:
- Male or female; age between 18 and 65 years.
- Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
- Patient with quantitative and qualitative score for inflammatory ocular signs > 20.
- Patient with Oxford grade > 2.
- Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
- Patient affiliated to a social security system or beneficiary of such a system.
Exclusion Criteria:
- Patient with active infectious keratitis (bacterial, parasitic or viral).
- Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
- Current contact lens wear, including scleral lenses.
- NSAID eye drops and any drops containing preservatives.
- Antibiotic, anti-viral, anti-parasitic eye drops.
- Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
- Ocular surgery in the 3 months preceding the inclusion in the study.
- Monophtalmic patient.
- Person deprived of liberty by a judicial or administrative decision.
- Adult subjected to a legal protection measure or unable to express his/her consent.
Sites / Locations
- CHU de Saint-Etienne Hôpital Nord
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LV-Visio-AMTRIX
Arm Description
Sutureless amniotic membrane supported by a biological ring.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
Preservation of epithelialization
Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250583
Brief Title
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
Official Title
Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Keratitis Resisting Healing Medical Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Low accrual rate
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TBF Genie Tissulaire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LV-Visio-AMTRIX
Arm Type
Experimental
Arm Description
Sutureless amniotic membrane supported by a biological ring.
Intervention Type
Biological
Intervention Name(s)
LV-Visio-AMTRIX
Intervention Description
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
Primary Outcome Measure Information:
Title
Keratitis healing within 15 days after the beginning of the treatment
Description
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
Secondary Outcome Measure Information:
Title
Stable or decreased score for inflammatory and clinical signs of the ocular surface
Description
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
Title
Stabilisation or decrease of pain evaluated on visual analog scale
Description
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
Title
Preservation of epithelialization
Description
Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system
Time Frame
15 days, 30 days, 45 days
Title
Change in eye dryness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female; age between 18 and 65 years.
Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
Patient with quantitative and qualitative score for inflammatory ocular signs > 20.
Patient with Oxford grade > 2.
Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
Patient affiliated to a social security system or beneficiary of such a system.
Exclusion Criteria:
Patient with active infectious keratitis (bacterial, parasitic or viral).
Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
Current contact lens wear, including scleral lenses.
NSAID eye drops and any drops containing preservatives.
Antibiotic, anti-viral, anti-parasitic eye drops.
Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
Ocular surgery in the 3 months preceding the inclusion in the study.
Monophtalmic patient.
Person deprived of liberty by a judicial or administrative decision.
Adult subjected to a legal protection measure or unable to express his/her consent.
Facility Information:
Facility Name
CHU de Saint-Etienne Hôpital Nord
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Learn more about this trial
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
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