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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect

Timeframe: Through study completion - average of 40 days

Trial details

NCT IDNCT05200000

SponsorTBF Genie Tissulaire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-20

View on ClinicalTrials.gov More Keratitis, Ulcerative trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.