Status:
TERMINATED
To Demonstrate the Non-inferiority of Eyestil Protection® Compared to Vismed® in Terms of Clinical Performance
Lead Sponsor:
SIFI SpA
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups. 3 months (plus a run in period of 15 days prior inclusion...
Detailed Description
Public hospitals and private practices specialized in ophthalmology Approximately 10 sites France Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of ...
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 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;
- 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 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03803722
Start Date
July 8 2019
End Date
June 30 2020
Last Update
May 9 2022
Active Locations (11)
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1
CHU d'Amiens
Amiens, France
2
Centre Rétine Anjou
Angers, France, 49000
3
Cabinet d'ophtalmologie Fosh
Bordeaux, France
4
Hopital Saint Vincent de Paul
Lille, France