Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Keratitis, Ulcerative
- Sponsor
- TBF Genie Tissulaire
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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
- Improvement of visual acuity(7 days, 15 days, 40 days)
- Re-epithelialization of the cornea(7 days, 15 days, 40 days)
- Improvement of dry eyes signs and symptoms(7 days, 15 days, 40 days)