Evaluation of Neovis® Total Multi Versus Systane® Balance on Ocular Dryness Associated With Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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This study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of improvement of stability of Tear film in patients with eye dryness associated to meibomian gland dysfunction, after 28 days of treatment.

Official Title
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Multicentric, Randomized, Comparative Clinical Study on the Evaluation of the Efficacy and Safety of Neovis® Total Multi Versus Systane® Balance on the Treatment of Ocular Dryness Associated With Meibomian Gland Dysfunction

Conditions
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Dry Eye, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Neovis Total Multi
* Device: Systane Balance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting dry eye symptoms for at least 6 months. OSDI (Ocular Surface Disease Index) ≥ 18 At least one eye eligible with: sum of peripheral corneal and conjunctival staining ≥ 4 and ≤ 9 (Oxford 0-15 grading scheme) AND sum of 3 measurements of Tear film Break-Up Time (TBUT) ≤ 15s Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands. Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period. Having given freely and expressly his/her informed consent. Able to comply with the study requirements, as defined in the present CIP, at the Investigator's appreciation. In France: subject being affiliated to a health social security system. Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end. Exclusion Criteria: Pregnant or nursing woman or planning a pregnancy during the study. Subject deprived of freedom by administrative or legal decision. Subject in a social or health institution Subject who is under guardianship or who is not able to express his/her consent. Use of contact lenses in either eye during the study. Far best-corrected visual acuity ≤ 1/10. Subject with severe ocular dryness with one of these conditions: Eyelid or blinking malfunction Corneal disorders not related to dry eye syndrome Ocular metaplasia Filamentous keratitis Corneal neovascularization History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months. History of ocular allergy or ocular herpes within the last 12 months. Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months. Any troubles of the ocular surface not related to dry eye syndrome. Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion. IOP > 21 mmHg Uncontrolled systemic disease Alcohol abuse Psychiatric disorders Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information Participation in other clinical studies in the last month Hypersensitivity to one or more components of the study product Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes Punctual plugs during the past 3 months Use of lipid-containing eye drops during the past 3 months Use of other therapeutic ophthalmics during the past 3 months Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational product<br> | Device: Neovis Total Multi<br>* 1 drop in each eye, 4 times per day<br>|
| Active Comparator: Comparator<br> | Device: Systane Balance<br>* 1 drop in each eye, 4 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear-Film Break Up Time (TBUT) | Evaluation of the non-inferiority of Neovis® Total Multi in comparison with Systane® Balance, in terms of TBUT improvement, on worse eye | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear-Film Break Up Time (TBUT) (performance) | Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye | 84 days | 
| Cornea and conjunctiva staining (Oxford score) (performance) | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye | 28 days | 
| Cornea and conjunctiva staining (Oxford score) (performance) | Main change from baseline of cornea and conjunctiva staining (Oxford score) in the worse eye and contralateral eye | 84 days | 
| Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 28 days | 
| Meibomian gland expression (performance) | Main change from baseline of meibomian gland expression score in the worse eye and contralateral eye | 84 days | 
| Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 28 days | 
| Meibum quality (performance) | Main change from baseline of meibum quality score in the worse eye and contralateral eye | 84 days | 
| Meiboscopy (performance) | Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye | 28 days | 
| Meiboscopy (performance) | Main change from baseline of the number of partially missing or dropout meibomian glands in the worse eye and contralateral eye | 84 days | 
| Eyelid margin abnormalities (performance) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 28 days | 
| Eyelid margin abnormalities (performance) | Main change from baseline of the eyelid margin abnormalities score in the worse eye and contralateral eye | 84 days | 
| OSDI (questionnaire) (performance) | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye | 28 days | 
| OSDI (questionnaire) (performance) | Main change from baseline of OSDI (Ocular Surface Disease Index) in the worse eye and contralateral eye | 84 days | 
| Global performance by the investigator (performance) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | 
| Global performance by the investigator (performance) | Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | 
| Global performance by the patient (performance) | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | 
| Global performance by the patient (performance) | Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | 
| Global tolerance by the investigator (safety) | Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | 
| Global tolerance by the investigator (safety) | Global tolerance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | 
| Global tolerance by the patient (safety) | Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 28 days | 
| Global tolerance by the patient (safety) | Global tolerance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory) | 84 days | 
| Intensity of ocular symptoms upon instillation (safety) | Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe) | 28 days | 
| Intensity of ocular symptoms upon instillation (safety) | Evaluation of intensity of ocular symptoms upon instillation on a scale from 0 (none) to 3 (severe) | 84 days | 
| Duration of ocular symptoms upon instillation (safety) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 28 days | 
| Duration of ocular symptoms upon instillation (safety) | Evaluation of duration of ocular symptoms upon instillation in seconds/minutes/hours | 84 days | 
| Frequency of ocular symptoms upon instillation (safety) | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) | 28 days | 
| Frequency of ocular symptoms upon instillation (safety) | Evaluation of frequency of ocular symptoms upon instillation on a scale from 1 (rarely) to 4 (very often) | 84 days | 
| Number of Adverse Events | Collection of ocular and systemic adverse events | 84 days |