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

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

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.

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