Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hyaluronic Acid 0.3% (FBV_01) vs Hyaluronic Acid 0.3% in Subjects in the Treatment From Moderate to Severe DED

Exclusion Criteria

• •Eye infection or clinically significant inflammation in both eyes (for example: Herpes simplex infections, corneal virus infections, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye);
• •History or evidence of eyelid abnormalities in either eye;
• •Use of topical cyclosporine, topical corticosteroids, or any other topical medication for the treatment of ocular pathologies in either eye within 7 days of study enrollment;
• •Patients being treated with chronic systemic therapies with analgesic, anti-inflammatory, corticosteroids, or opioids;
• •History of ocular surgery (including laser procedures or refractive surgery) in either eye 7 days prior to enrollment;
• •History or evidence of severe or uncontrolled systemic or autoimmune disease does not allow participation in the study or could impair the results;
• •Patients being treated with drugs and/or medical devices and/or supplements for neuropathic pain (e.g., SNRIs (duloxetine, venlafaxine), pregabalin, gabapentin, TCAs (nortriptyline, amitriptyline));
• •Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
• •Participation in another clinical trial within 30 days prior to the screening visit;
• •History of administration or abuse of drugs, medications, or alcohol;
• •Women of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) will be excluded from participation in the study if they meet any of the following conditions:
• •1. are currently pregnant or,
• •2. have a positive urine pregnancy test result at visit 1,
• •3. intend to become pregnant during the study treatment period or,
• •4. are breastfeeding or, unwilling to resort to highly effective birth control measures, such as: hormonal contraceptives oral, implanted, transdermal or injected and/or mechanical barrier methods spermicidal concurrently with a barrier such as a condom or diaphragm or IUD during the entire course of the study and 30 days after the end of the treatment period;
• •Subject unable to follow clinical investigation procedures and follow-up visits;
• •Any other medical condition which, in the opinion of the Investigator, could influence participation in the clinical investigation or compromise its results.