Vit-A-Vision® Clinical Investigation

Launched by OMNIVISION GMBH · Sep 12, 2024

Keywords

ClinConnect Summary

The Vit-A-Vision® Clinical Investigation is a study looking at an ointment designed to help relieve discomfort in the eyes, such as dryness, burning, and irritation. This trial focuses on people who experience symptoms of dry eye disease, which can make daily activities like reading and using computers difficult. To participate, you need to be at least 18 years old and have specific signs of dry eye, such as a certain score on the Ocular Surface Disease Index, which measures how much your eyes are bothering you. Participants should also be willing to use the ointment as instructed throughout the study and attend follow-up visits.

If you join the trial, you'll be using the Vit-A-Vision ointment for about 33 days and will be monitored to see how it helps with your eye symptoms. It's important to note that some individuals, such as those with severe dry eye, certain allergies, or recent eye surgeries, may not be eligible to participate. This study aims to gather more information about how effective this ointment is in treating dry eye symptoms, which could lead to better options for people suffering from this common condition.

Gender

ALL

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