A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® (047/SI)
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|ClinicalTrials.gov Identifier: NCT03803748|
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : May 27, 2020
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 the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices.
Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes||Device: Eyestil Plus®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a national, prospective, multicenter, comparative, randomized, double-blinded non-inferiority study performed in two parallel groups.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind|
|Official Title:||A Prospective Multicenter, Comparative, Randomized, Double-blind, Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® in Patients With Moderate to Severe Dry Eye Syndrome|
|Actual Study Start Date :||July 17, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Eyestil Plus®
It's a clinical comparative performance study. Eyestil Plus® eyedrops multidose to be not inferior to Vismed multidose eye drops. Eyestil Plus is an ophthalmic aqueous formulation, multidose sterile preservative free, medical device, class IIB and CE marked. It contains 0.4% sodium hyaluronate. It is not available yet in the French Market.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period,
Device: Eyestil Plus®
• 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 staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis
No Intervention: Vismed
Vismed Multi® is also a sterile multidose preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period.
The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
- Primary endpoint/clinical performance by Oxford scale [ Time Frame: between Day 1 and Day 35 ±4 ]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 timepoints of the Global Ocular Staining Score of the study eye (GOSS) and the comparison between both treatment groups. 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 TBUT test. This full procedure will be performed 3 times per eye and per time point. 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/clinical performance by Oxford scale [ Time Frame: between Day 1 and Day 84 ±7 days ]The between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale. This refers to the average variation between both time points of the Global Ocular Staining Score of the study eye (GOSS) and the comparison between both treatment groups. 0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
- secondary endpoint/clinical performance by Schirmer Test [ Time Frame: test 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 symptoms by Ocular Symptoms Disease Index (OSDI) score [ Time Frame: 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.
- secondary endpoint/patient symptoms by Dry Eye-Related Quality -of-Life(DEQS) questionnaire [ Time Frame: 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) questionnaire. 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: Day 1 and Day 84 ±7 ]The description of all adverse events, related and unrelated to the medical devices, anticipated or unanticipated.
- secondary endpoint/Investigator overall treatment satisfaction using by a four-point scale [ Time Frame: 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. 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.
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): NCT03803748
|Contact: Pierre Jean PISELLA, MD, Pr||+33 firstname.lastname@example.org|
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