Vizol S DIGI EYE Efficacy and Safety Study in Patients With Dry Eye

Inclusion Criteria: * ≥18 years of age; * Diagnosis of moderate to severe dry eye disease (DED) with a baseline * Ocular Surface Disease Index (OSDI) score ≥23 (approximately 15% of the population should wear contact lenses); * Tear Film Break-Up Time (TBUT) \<10 s in one or both eyes at baseline; * National Eye Institute (NEI) score for corneal fluorescein surface staining \>5/15 and for conjunctival fluorescein surface staining \>6/18 at baseline; * Best corrected visual acuity (BCVA) of ≥20/80 (or ≥55 letters score or ≥0.6 Early Treatment Diabetic Retinopathy Study log of the minimum angle of resolution value) in both eyes at screening; * Use of electronic devices (e.g., computers, laptops, smart phones, tablets, televisions (TVs), electronic book readers) with digital screens for more than 6 hours daily; * Use of eyelid hygiene for at least 14 days prior to screening; * Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the patients participating in the clinical trial. Exclusion Criteria: * History of hypersensitivity or intolerance to any component of investigational product (IP); * History of hypersensitivity to fluorescein; * Any active ocular disease or any anterior ocular surface findings (diseases and irregularities) other than dry eye disease; * Ocular or refractive surgery (e.g., LASIK, photorefractive keratectomy (PRK) etc.) within the last 12 mon…