Vit-A-Vision® Clinical Investigation

Exclusion Criteria

• •Known hypersensitivity (allergy) to any of the ingredients of Vit-A-Vision: vaseline, paraffin, adeps lanae, vitamin A palmitate, dexpanthenol, α-Tocopherol acetate or cetylstearyl alcohol.
• •Severe forms of dry eye syndrome with OSDI \> 55
• •Not willing to discontinue contact lens use during the study period
• •Refractive surgery within the last 12 months and/or any other ocular surgery or ocular trauma/injury within the last 4 months
• •Acute inflammatory or ocular surface disease, Sjögren's Syndrome (autoimmune disease), Stevens-Johnson Syndrome, ocular pemphigoid, and radiation-induced dry eye.
• •Use of systemic medication that could affect vision or dry eye, including essential fatty acids, unless dose has been constant for more than 3 months and is not expected to change during the study
• •Systemic concomitant medications:
• •* Corticosteroids within 2 months before enrolment and for the whole study period and / or
• •* Tetracyclines within 1 month before selection and for the whole study period.
• •* Vitamin A supplements intake
• •Use of topical ophthalmic medication during the study or within 2 weeks prior to the first visit, other than artificial tears
• •Use of topical cyclosporine within 3 months prior to the first visit
• •Use of other eye drops/sprays (based on liposomic and/or oily products) during the present investigation
• •Abnormality of the nasolacrimal drainage apparatus
• •Permanent occlusion of lacrimal puncta in any eye
• •Use of temporary punctal plug in any eye within 2 months before the selection visit
• •Previous enrolment into the current investigation
• •Patients who participated in any other clinical trial within the last 30 days before selection
• •Children, pregnant and breastfeeding women
• •Participants under the influence of excessive alcohol, narcotics or benzodiazepines
• •Other diseases or characteristics judged by the investigator to be incompatible with the frequent assessments needed in this study or with reliable instillation of the products (for example: mental or physical incapacity, language comprehension, psychological disorders, dementia, geographical localisation, etc...).
• •Individuals who are deprived of liberty pursuant to an administrative order or court order or approval