SAFETY AND PERFORMANCE OF A NEW MEDICAL DEVICE ON POST CATARACT SURGERY DRY EYE DISEASE

Inclusion criteria

• 2. Age: > 18 years and less than 78 years old. 3. Subject who requires a unilateral cataract surgery (phacoemulsification and intra ocular lens implantation) or bilateral cataract surgery with delay of maximum 4 days between two eyes operation.

• Subject with mild to moderate dry eye at the pre-operative visit with the following scores:
• OSDI (Ocular Surface Disease Index) ≥ 13 and ≤ 32
• Schirmer test in the operated eye ≥ 5 mm/5min and ≤ 15 mm/5min And/or
• Non-invasive break-up time (NIBUT) in the operated eye: sum of 3 measurement ≥ 5 sec and ≤ 15 sec 5. Patient who did not use artificial tears 1 week before the screening visit. 6. Patient having given freely and expressly his informed consent. 7. Patient psychologically able to understand the study related information and to give a written informed consent.

• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion criteria

In terms of population

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Subject suspected to be non-compliant according to the investigator's judgment.
• Patient using contact lens during screening period and the entire study (even if prescribed by the investigator after surgery).

In terms of associated pathology

• Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
• Subject with severe eye dryness
• Patient with palpebral malposition with a tendency to incomplete blinking +/- scleral show
• Patient with general pathologies that can cause dry eye syndrome like: thyroid disorder, cutaneous rosacea, acne and/or iatrogenic effects of isotretinoin treatment.
• Presence of ocular comorbidities such as glaucoma, uveitis or cystoid macular oedema.
• Neuropathic causes of dry eye ( long-standing contact lens wearing, previous ocular herpes infections)
• Past or active ocular surface diseases (any corneal disease, cicatricial conjunctivitis, ocular surface burns, keratinization of the eyelid margin, Sjogren syndrome, corneal trauma)
• Ocular or general factors predisposing the patient to an increased risk for intraoperative complications, according to investigator's evaluation
• Know hypersensitivity to any component of the study product Relating to previous or ongoing treatment
• Subject with other ocular surgery in the 12 previous months.
• Subject with lid surgery in the 3 previous months
• Subject who received systemic non-steroidal anti-inflammatory drugs, immunosuppressants, corticoids or any medication that could interfere with lacrimal function during the 3 weeks prior to the study.
• Subject who received topical antibiotics, topical NSAIDs, topical steroid or topical cyclosporine in either eye in the past month.