evaluation of neovis® total multi versus systane® balance on ocular dryness associated with meibomian gland dysfunction

Conditions: Dry Eye; Meibomian Gland Dysfunction

Summary: 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.


Eligibility criteria:
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