A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi®
NCT ID: NCT03803748
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2019-07-17
2022-08-31
Brief Summary
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Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Eyestil Plus®
It's a clinical comparative performance study. Eyestil Plus® eyedrops multidose to be not inferior to Vismed multidose eye drops. Eyestil Plus is an ophthalmic aqueous formulation, multidose sterile preservative free, medical device, class IIB and CE marked. It contains 0.4% sodium hyaluronate. It is not available yet in the French Market.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period,
Eyestil Plus®
• To demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis
Vismed
Vismed Multi® is also a sterile multidose preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period.
The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
No interventions assigned to this group
Interventions
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Eyestil Plus®
• To demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis
Eligibility Criteria
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Inclusion Criteria
* Patients understanding the study, willing to follow the instructions and providing their written Informed Consent Form to participate
* Patients with moderate up severe dry eye with keratoconjunctivitis sicca diagnosed at least 4 weeks before the screening visit
* Patients using artificial tears at least once a day for at least 4 weeks months before the screening visit\*
* Patients with corneal/conjunctival lesions consistent with a diagnosis of keratoconjunctivitis measured by tests of staining: i.e. the overall score of the corneal staining test must be ≥ 3 and ≤ 9 on the 15-point Oxford scale
* And at least one of the following element:
Tear volume decreased: must be either present a Schirmer test ≥ 3 mm and ≤ 9 mm / 5 minutes or the sum of 3 consecutive measurements of the tear film break-up time (TBUT) ≤ 30s for at least one eye An OSDI score ≥18
\- Covered by healthcare insurance.
Exclusion Criteria
* Any systemic disease that is not well controlled for at least 2 months (e.g. lupus, rheumatoid arthritis, thyroiditis…) according to clinical judgment
* Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor
* Patients with at least one of the following concomitant ocular inflammatory disease: Stevens Johnson Disease, Atopic Keratoconjunctivitis; Scarlet Eye Pemphigoid
* Patients with anomalies of the eyelid, sucking, infectious conjunctivitis, pterygia, and/or a glaucoma treated with eyedrops
* Presence of graft versus host disease (GVHD)
* Patients who have undergone surgery in the eye, within three months before the study enrolment
* Patients who have undergone corneal transplantation or refractive surgery or plan to undergo any eye surgery in the next four months
* Patients with known or suspected eye allergy
* Patients with a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study
* Female pregnant, planning a pregnancy during the study period and nursing an infant
* Patients who are participating or have participated in other clinical trial with investigational drug or device within 30 days prior to screening
* Patients unable to be compliant with the study procedures and requirements, according to the opinion of the investigator
* Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
18 Years
ALL
No
Sponsors
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SIFI SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Pierre Jean Pisella, MD, Pr
Role: PRINCIPAL_INVESTIGATOR
HOPITAL BRETONNEAU
Locations
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CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
Chu Morvan
Brest, , France
CHU François Mitterand
Dijon, , France
Hôpital de la Croix Rousse
Lyon, , France
Centre Monticelli
Marseille, , France
Hopital La Timone Adultes
Marseille, , France
CHU de Nice - Hôpital Pasteur
Nice, , France
CHU Saint Etienne/Hôpital Nord
Saint-Etienne, , France
Hopital Bretonneau
Tours, , France
Instituto Oftalmologico Fernandez-Vega
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Recoletas Campo Grande
Valladolid, , Spain
Countries
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Other Identifiers
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047/SI
Identifier Type: -
Identifier Source: org_study_id