Clinical trial NCT05200000: Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
Official title: Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratitis, Ulcerative
Corneal Ulcer
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
timeFrame: Through study completion - average of 40 days
Secondary outcomes:
measure: Re-epithelialization of the cornea
timeFrame: 7 days, 15 days, 40 days
measure: Improvement of dry eyes signs and symptoms
timeFrame: 7 days, 15 days, 40 days
measure: Improvement of visual acuity
timeFrame: 7 days, 15 days, 40 days
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Hôpital Michallon, CHU de Grenoble
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac, CHU de Montpellier
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
city: Rouen
country: France
facility: Hôpital Charles-Nicolle, CHU de Rouen
city: Saint-Priest-en-Jarez
country: France
facility: Hôpital Nord, CHU de Saint-Etienne
Study officials:
References: