Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT06596733
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old
* Ocular Surface Disease Index (OSDI) ≧ 16
* Median of three consecutive non-invasive tear film break-up time (NIBUT) test results less than or equal to 10 seconds in at least one eye
* Willingness to apply the medical device under evaluation as per Instructions for Use (IfU) during the entire study duration (i.e., 33 ± 3 days)
* Willingness to undergo a follow-up visit at day 15 ± 3 and 33 ± 3 after enrolment
* Good understanding of written and oral speaking languages used at the centre where the study will be carried out
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06596733
Study Brief:
Protocol Section:
NCT06596733