To Demonstrate the Non-inferiority of Eyestil Protection® Compared to Vismed® in Terms of Clinical Performance

NCT03803722 | Terminated

• 1 other identifier: 048/SI
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 11

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) Patients with moderate to severe dry eye syndrome.

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• Primary endpoint/clinical performance by Oxford scale

  Clinical performance of the medical device under investigation: the between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0 to 15). This refers to the average variation between both time points of the Global Ocular Staining Score of the study eye (GOSS). 0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15

  between Day 1 and Day 35 ±4.

Secondary Outcomes (6)

• Secondary endpoint/clinical performance by TBUT test

  between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7

• Secondary endpoint/patient reported outcome by DEQS questionnaire

  between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7

• Secondary endpoint/safety

  between Day 1 and Day 84 ±7

• Secondary endpoint/clinical performance by Oxford scale

  between Day 1 and Day 84 ±7

• Secondary endpoint/clinical performance by Schirmer test

  between [Day 1 and Day 84 ±7]

Other Outcomes (1)

• Investigator's overall treatment satisfaction (PRO)

  at [Day 35±4 and Day 84 ±7].

Study Arms (2)

Arm A Eyestil Protection®

EXPERIMENTAL

No inferiority of Eyestil Protection® unidose versus Vismed® unidose The intervention consists of Eyestil Protection® : sterile preservative free, medical device, class IIa and CE marked. It contains 0.2% xanthan gum, presented in 0.3 ml unidose containers. It is not available yet on the French Market. dosage: 6 drops a day for three months period.

Device: Eyestil Protection® unidose

Arm B Vismed®

NO INTERVENTION

Vismed®: sterile preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate, presented in 0.3 ml unidose containers. It is already on the French market. dosage: 6 drops a day for three months period.

Interventions

Eyestil Protection® unidose DEVICE

to demonstrate the non-inferiority of Eyestil Protection® in terms of performance and safety, when compared to Vismed® in treatment of dry eye disease.

Arm A Eyestil Protection®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• SIFI SpA: lead

Study Sites (11)

CHU d'Amiens

Amiens, France

Location

Centre Rétine Anjou

Angers, 49000, France

Location

Cabinet d'ophtalmologie Fosh

Bordeaux, France

Location

Hopital Saint Vincent de Paul

Lille, France

Location

Hopital Edouard Herriot

Lyon, France

Location

Hôpital Saint Joseph

Marseille, France

Location

Chu Kremlin-Bicetre

Paris, 94270, France

Location

APHP - Hôpital Cochin

Paris, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Marc Labetoulle, MD; Pr

  CHU KREMLIN-BICETRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single Blind: investigator masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%. Single masked. Medical Device

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 15, 2019
• Study Start: July 8, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

ES (1); FR (10)