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

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 months from screening;
• •Current punctual occlusion of any type;
• •History of ocular trauma;
• •History of herpes simplex or herpes zoster keratitis;
• •History of any type of corneal ulcers;
• •Any other acute or chronic disease which may interfere with the aims of the clinical trial or other relevant ocular pathology judged by the investigator that preclude safe administration of the IPs;
• •Systemic diseases that alter the ocular surface;
• •History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator;
• •History of malignancy (other than localized basal cell carcinoma of the skin or in situ cervical cancer);
• •Use any topical ophthalmic medication within the last 30 days (except for artificial tears or lubricants; patients will be required to discontinue any other artificial tear or lubricants within the last 14 days and during the trial);
• •Use of systemic medications that may contribute to dry eye (unless on a stable regimen for ≥30 days before screening and throughout the study);
• •History of or current drug or alcohol dependence;
• •Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test;
• •History of Coronavirus Disease 2019 (COVID-19) within the last 30 days (to be defined in line with national requirements);
• •History of direct contact with insufficient protection to persons with COVID-19 within the last 14 days (to be defined in line with national requirements);
• •Pregnancy or breastfeeding;
• •Female patients with childbearing potential (any female after menarche unless postmenopausal for ≥12 months, or surgically sterilized) who are not willing to use a highly effective method of contraception during the study;
• •Positive pregnancy test, for female patients with childbearing potential only;
• •Patients suspected or known not to follow instructions;
• •Patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial;
• •Participation in another clinical trial within 3 months before screening or over a period of 5 half-lives, or double duration of the biological effect of the investigational product received, whichever is longer.