To Demonstrate the Non-inferiority of Eyestil Protection® Compared to Vismed® in Terms of Clinical Performance
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|ClinicalTrials.gov Identifier: NCT03803722|
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : May 27, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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 Description:||Single Blind: investigator masked|
|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|
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 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 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).
- 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. .
- 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
- 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
- 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).
- 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.
- 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.
• 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].
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
|Contact: Marc Labetoulle, MD||+33 email@example.com|
|Contact: Soumaya EL AMALI firstname.lastname@example.org|
|Principal Investigator: Soumaya El Amali, MD|
|Centre Rétine Anjou||Recruiting|
|Angers, France, 49000|
|Contact: Mounir BENZERROUG, MD email@example.com|
|Principal Investigator: Mounir BENZERROUG, MD|
|Cabinet d'ophtalmologie Fosh||Recruiting|
|Principal Investigator: Bruno MORTEMOUSQUE|
|Hopital Saint Vincent de Paul||Recruiting|
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|Principal Investigator: Ti ha chau Tran, MD|
|Hopital Edouard Herriot||Recruiting|
|Contact: Carole Burillon, MD email@example.com|
|Principal Investigator: Carole Burillon, MD|
|Hôpital Saint Joseph||Recruiting|
|Contact: Dominique Cardiou-Arzouni, MD firstname.lastname@example.org|
|Principal Investigator: Dominique Cardiou-Arzouni, MD|
|Paris, France, 94270|
|Contact: Marc Labetoulle, MD +33 145213690 email@example.com|
|Principal Investigator: Marc Labetoulle, MD|
|APHP - Hôpital Cochin||Recruiting|
|Contact: Jean Louis Bourges, MD Jeanfirstname.lastname@example.org|
|Principal Investigator: Jean Louis Bourges, MD|
|Centre Hospitalier Universitaire de Rennes||Recruiting|
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|Principal Investigator: Frédéric Mouriaux, MD|
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|Principal Investigator: Tristan Bourcier, MD|
|Hospital Universitario Miguel Servet||Not yet recruiting|
|Contact: Luis Pablo Julvez, MD|
|Principal Investigator: Luis Pablo Julvez, MD|
|Principal Investigator:||Marc Labetoulle, MD; Pr||CHU KREMLIN-BICETRE|