Keratitis, UlcerativePhase 1NCT05200000
Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
A Phase 1 study testing SygeLIX-Coll-T in people with Keratitis, Ulcerative and Corneal Ulcer, run by TBF Genie Tissulaire at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Keratitis, Ulcerative, Corneal Ulcer
- What is being tested?
- SygeLIX-Coll-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Jan 2020to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Michallon, CHU de Grenoble
La Tronche, 38700
Hôpital Gui de Chauliac, CHU de Montpellier
Montpellier, 34295
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Hôpital Charles-Nicolle, CHU de Rouen
Rouen, 76000
Hôpital Nord, CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
About this study
Official title: Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
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.
- Conditions
- Keratitis, Ulcerative, Corneal Ulcer
- Being tested
- SygeLIX-Coll-T
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SygeLIX-Coll-TBiological
Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.
| Study group | Role | What they receive |
|---|---|---|
| SygeLIX-Coll-T | Experimental | 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. Receives: Biological: SygeLIX-Coll-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion - average of 40 days
Secondary outcomes (3)
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)
Measured: 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
Measured: 7 days, 15 days, 40 days
Improvement of visual acuity
Visual acuity evaluated on Monoyer chart
Measured: 7 days, 15 days, 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start8 Jan 2020
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200000
- Sponsor's protocol ID
- SygeLIX-C-TBF1
- Other IDs
- 2019-A00866-51
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
- ClinicalTrials.gov ID
- NCT05200000
- Acronym / sponsor ID
- SygeLIX-C-TBF1
- Conditions
- Keratitis, Ulcerative, Corneal Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SygeLIX-Coll-T | Experimental | Biological: SygeLIX-Coll-TExtract 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SygeLIX-Coll-TReconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops. | Biological | SygeLIX-Coll-T |
Primary outcome
Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
Time frame: 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
3 secondary outcomes
Re-epithelialization of the cornea
Time frame: 7 days, 15 days, 40 days
Improvement of dry eyes signs and symptoms
Time frame: 7 days, 15 days, 40 days
Improvement of visual acuity
Time frame: 7 days, 15 days, 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SygeLIX-Coll-T in people with Keratitis, Ulcerative and Corneal Ulcer, run by TBF Genie Tissulaire at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect (time frame: Through study completion - average of 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.