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Completed

NCT Number: NCT05200000

Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis

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.

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Key information

Conditions

Keratitis, Ulcerative Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections Keratitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hôpital Michallon, CHU de Grenoble, La Tronche, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SygeLIX-Coll-T

Biological

Reconstituted suspension made of Trehalose and chemically treated, grinded, freeze-dried and sterilized Wharton's Jelly used by the patient as eye drops.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Re-epithelialization of the cornea

    Time frame: 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)

  2. Improvement of dry eyes signs and symptoms

    Time frame: 7 days, 15 days, 40 days

    Severity of dry eye evaluated using Ocular Surface Disease Index (OSDI) questionnaire

  3. Improvement of visual acuity

    Time frame: 7 days, 15 days, 40 days

    Visual acuity evaluated on Monoyer chart

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study title

Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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