Status:
COMPLETED
A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi®
Lead Sponsor:
SIFI SpA
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect t...
Detailed Description
The aim of the study is 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 st...
Eligibility Criteria
Inclusion
- Adult patients, male or female, of at least 18 years of age at the screening visit
- 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
- Patients with medical history of herpetic keratitis, peripheral ulcerative keratitis, sclerites, diabetic retinopathy
- 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).
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03803748
Start Date
July 17 2019
End Date
August 31 2022
Last Update
December 23 2022
Active Locations (12)
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1
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
2
Chu Morvan
Brest, France
3
CHU François Mitterand
Dijon, France
4
Hôpital de la Croix Rousse
Lyon, France