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

Multicentre, Randomized, Controlled, Double-blind, Parallel Design Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vizol S DIGI EYE in the Adult Patient Population With Moderate to Severe Dry Eye Disease for up to 28 Days

The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S DIGI EYE, a new eye drops, solution developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 28 days.

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 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.