Status:
COMPLETED
Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Keratitis, Ulcerative
Corneal Ulcer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05200000
Start Date
January 8 2020
End Date
June 20 2023
Last Update
February 20 2024
Active Locations (6)
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1
Hôpital Michallon, CHU de Grenoble
La Tronche, France, 38700
2
Hôpital Gui de Chauliac, CHU de Montpellier
Montpellier, France, 34295
3
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75012
4
Hôpital Fondation Adolphe de Rothschild
Paris, France, 75019