Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SygeLIX-Coll-T 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.
|
Outcome Measures
Primary Outcome Measures
- Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect [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
Secondary Outcome Measures
- Re-epithelialization of the cornea [7 days, 15 days, 40 days]
Epithelialization assessed by the Oxford score after fluorescein instillation in the eye (0: no corneal staining to 5: severe corneal staining)
- Improvement of dry eyes signs and symptoms [7 days, 15 days, 40 days]
Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire
- Improvement of visual acuity [7 days, 15 days, 40 days]
Visual acuity evaluated on Monoyer chart
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Paris | France | 75012 | |
2 | CHU de Saint-Etienne Hôpital Nord | Saint-Priest-en-Jarez | France | 42270 |
Sponsors and Collaborators
- TBF Genie Tissulaire
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SygeLIX-C-TBF1
- 2019-A00866-51