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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803722
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
SIFI SpA

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.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Device: Eyestil Protection® unidose Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%. Single masked. Medical Device
Masking: Single (Investigator)
Masking Description: Single Blind: investigator masked
Primary Purpose: Other
Official Title: A Prospective Multicenter, Comparative, Randomized, Single-blind, Non-inferiority Study of Eyestil Protection® Unidose Versus Vismed® Unidose in Patients With Moderate to Severe Dry Eye Syndrome
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Arm A Eyestil Protection®

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

No Intervention: Arm B Vismed®

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.




Primary Outcome Measures :
  1. Primary endpoint/clinical performance by Oxford scale [ Time Frame: between Day 1 and Day 35 ±4. ]

    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



Secondary Outcome Measures :
  1. Secondary endpoint/clinical performance by TBUT test [ Time Frame: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7 ]

    The between-group comparisons of the average variation of the time obtained at the tear break up time test (TBUT). This full procedure will be performed 3 times per eye and per time point. Each obtained time will be recorded by the investigator in the eCRF. At screening and at baseline visits, the sum of these 3 times for at least one eye to be eligible must be ≤ 30 seconds.

    Conventionally TBUT's measures shorter than 10 seconds can be referred to tear film instability and measures shorter than 5 seconds, usually, are undoubtable sign of dry eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).


  2. Secondary endpoint/patient reported outcome by DEQS questionnaire [ Time Frame: between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7 ]

    The between-group comparisons of the average variation of Dry Eye-Related Quality-of-Life (DEQS) general score. It is a validated 15-item scale divided into 2 subscales related to dry eye symptoms and its influence on daily life:

    The frequency is scored on a 5-point Likert scale ranging from 0 (no symptom) to 4 (highest frequency).

    • The degree is scored on a 4-point Likert scale ranging from 1 to 4, a larger number indicates a greater burden.

    The summary score ranges from 0 to 100, higher score indicates higher disability. .


  3. Secondary endpoint/safety [ Time Frame: between Day 1 and Day 84 ±7 ]
    The description of all adverse events, related and unrelated to the medical devices, anticipated or unanticipated

  4. Secondary endpoint/clinical performance by Oxford scale [ Time Frame: between Day 1 and Day 84 ±7 ]
    The between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0-15).This refers to the average variation between both time points of the of the Global Ocular Staining Score of the study eye (GOSS) and the comparison between both treatment groups. -5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15

  5. Secondary endpoint/clinical performance by Schirmer test [ Time Frame: between [Day 1 and Day 84 ±7] ]

    The between-group comparisons of the average variation of the paper length obtained at the Schirmer Test. The Schirmer test without anesthesia will be here performed to measure the rate of secretion of tears produced by the study eye over 5 minutes.The cut-off value for a severe dry eye in the first one is 6 mm. But the cut-off that will here use will be 9 mm with the following interpretation:

    • Normal = ≥ 10 millimeters (mm) of tears,
    • Dry Eye = ≤ 9 mm of tears A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).

  6. Secondary endpoint/patient reported outcome by OSDI score [ Time Frame: between [Day 1 and Day 35 ±4] and [Day 1 and Day 84 ±7] ]

    The between-group comparisons of the average variation of Ocular Symptoms Disease Index (OSDI) score. The patient's dry eye symptoms will be assessed with the Ocular Surface Disease Index (OSDI). It is a validated 12-questions scale for patients that covers a broad spectrum of ocular surface symptoms, the severity of such symptoms for patients and how these symptoms affect/impact visual function over a 1-week recall period. Its scores range from 0 to 100, with higher scores indicating greater severity of disease.Positive result is considered when the OSDI score is ≥ 18.To be consistent with the IMD indication, patient with moderate to severe dry eye thus with an OSDI ≥ 18 will be selected. If the patient's OSDI score will be strictly below 18 at the screening or baseline visit, s/he will be considered as a screening failure.

    Each item response will be collected in the study database since given separately to patients.



Other Outcome Measures:
  1. Investigator's overall treatment satisfaction (PRO) [ Time Frame: at [Day 35±4 and Day 84 ±7]. ]

    The between group comparison using on a four-point scale assessing investigator's overall satisfaction on the treatment's clinical performance

    • The between group comparison using on a four-point scale assessing investigator's overall satisfaction on the treatment's clinical performance at [Day 35±4 and Day 84 ±7].

    Overall investigator' satisfaction of the product's clinical performance will be assessed at the end of the patient follow-up period on a four-point scale from 0: very satisfactory, 1: satisfactory; 2: somewhat unsatisfactory; 3: unsatisfactory Safety • The description of all adverse events, related and unrelated to the medical devices, anticipated or unanticipated.

    Exploratory endpoints

    • PROs: the between-group comparisons of the average variation of the DEQS subscale scores between [Day 1 and Day 35 ±4] and [Day 1 and Day 84 ±7].




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803722


Contacts
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Contact: Marc Labetoulle, MD +33 145213690 marc.labetoulle@aphp.fr

Locations
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France
CHU d'Amiens Recruiting
Amiens, France
Contact: Soumaya EL AMALI       elamali.soumaya@chu-amiens.fr   
Principal Investigator: Soumaya El Amali, MD         
Centre Rétine Anjou Recruiting
Angers, France, 49000
Contact: Mounir BENZERROUG, MD       mounir.benzerroug@gmail.com   
Principal Investigator: Mounir BENZERROUG, MD         
Cabinet d'ophtalmologie Fosh Recruiting
Bordeaux, France
Principal Investigator: Bruno MORTEMOUSQUE         
Hopital Saint Vincent de Paul Recruiting
Lille, France
Contact: Ti ha chau Tran, MD       Tran.ha-chau@ghicl.net   
Principal Investigator: Ti ha chau Tran, MD         
Hopital Edouard Herriot Recruiting
Lyon, France
Contact: Carole Burillon, MD       carole.burillon@chu-lyon.fr   
Principal Investigator: Carole Burillon, MD         
Hôpital Saint Joseph Recruiting
Marseille, France
Contact: Dominique Cardiou-Arzouni, MD       dcadiou@hopital-saint-joseph.fr   
Principal Investigator: Dominique Cardiou-Arzouni, MD         
Chu Kremlin-Bicetre Recruiting
Paris, France, 94270
Contact: Marc Labetoulle, MD    +33 145213690    marc.labetoulle@aphp.fr   
Principal Investigator: Marc Labetoulle, MD         
APHP - Hôpital Cochin Recruiting
Paris, France
Contact: Jean Louis Bourges, MD       Jean-louis.bourges@htd.aphp.fr   
Principal Investigator: Jean Louis Bourges, MD         
Centre Hospitalier Universitaire de Rennes Recruiting
Rennes, France
Contact: Frédéric Mouriaux, MD       frederic.mouriaux@chu-rennes.fr   
Principal Investigator: Frédéric Mouriaux, MD         
CHU Strasbourg Recruiting
Strasbourg, France
Contact: Tristan Bourcier, MD       tristan.bourcier@chru-strasbourg.fr   
Principal Investigator: Tristan Bourcier, MD         
Spain
Hospital Universitario Miguel Servet Not yet recruiting
Zaragoza, Spain
Contact: Luis Pablo Julvez, MD         
Principal Investigator: Luis Pablo Julvez, MD         
Sponsors and Collaborators
SIFI SpA
Investigators
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Principal Investigator: Marc Labetoulle, MD; Pr CHU KREMLIN-BICETRE
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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT03803722    
Other Study ID Numbers: 048/SI
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases