Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis (NCT05200000) | Clinical Trial Compass
CompletedPhase 1
Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
France20 participantsStarted 2020-01-08
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
What they're measuring
1
Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
Timeframe: Through study completion - average of 40 days