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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.
The aim of the study is 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. Secondly, the study is aimed at evaluating the safety profile of the product and the patients' quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eyestil Plus® | Experimental | 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, |
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| Vismed | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyestil Plus® | Device | • 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint/clinical performance by Oxford scale | 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 | between Day 1 and Day 35 ±4 |
| Measure | Description | Time Frame |
|---|---|---|
| secondary endpoint/clinical performance by TBUT test | 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). |
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Inclusion Criteria:
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 An OSDI score ≥18
- Covered by healthcare insurance.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Jean Pisella, MD, Pr | HOPITAL BRETONNEAU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | ||||
| Chu Morvan |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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This is a national, prospective, multicenter, comparative, randomized, double-blinded non-inferiority study performed in two parallel groups.
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Double blind
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| between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7 |
| secondary endpoint/clinical performance by Oxford scale | 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 | between Day 1 and Day 84 ±7 days |
| secondary endpoint/clinical performance by Schirmer Test | 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:
| test between Day 1 and Day 84 ±7 |
| secondary endpoint/patient symptoms by Ocular Symptoms Disease Index (OSDI) score | 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. | Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7 |
| secondary endpoint/patient symptoms by Dry Eye-Related Quality -of-Life(DEQS) questionnaire | 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 | Day 1 and Day 35 ±4 and [Day 1 and Day 84 ±7 |
| secondary endpoint/safety | The description of all adverse events, related and unrelated to the medical devices, anticipated or unanticipated. | Day 1 and Day 84 ±7 |
| secondary endpoint/Investigator overall treatment satisfaction using by a four-point scale | 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. | Day 35±4 and Day 84 ±7 |
| Brest |
| France |
| CHU François Mitterand | Dijon | France |
| Hôpital de la Croix Rousse | Lyon | France |
| Centre Monticelli | Marseille | France |
| Hopital La Timone Adultes | Marseille | France |
| CHU de Nice - Hôpital Pasteur | Nice | France |
| CHU Saint Etienne/Hôpital Nord | Saint-Etienne | France |
| Hopital Bretonneau | Tours | France |
| Instituto Oftalmologico Fernandez-Vega | Madrid | Spain |
| Hospital Universitario Virgen Macarena | Seville | Spain |
| Hospital Recoletas Campo Grande | Valladolid | Spain |