Vit-A-Vision® Clinical Investigation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOmniVision GmbH

About this trial

Symptoms of ocular discomfort include dryness, burning, stinging, photophobia, foreign body sensation and contact lens intolerance. These symptoms may affect basic daily activities, such as reading, driving, and working with computers. In case of moderate to severe conditions, dry eye disease is also associated with significant pain. Dry eye disease (DED) affects hundreds of millions of people throughout the world and is one of the most frequent causes of patient visits to eye care practitioners. Diagnosing, staging and determining the efficacy of therapy in DED is often challenging due to low correlation between signs and symptoms. Furthermore, its management is complicated because of its multifactorial aetiology. In general, management approaches begin with conventional, low-risk and easily accessible patient-applied therapies such as over-the-counter lubricants for early-stage disease, and progress to more advanced therapies for more severe forms of DED. In this regard, tear supplementation with ocular lubricants (artificial tears) is considered the first-line therapy and is often the only therapy used in mild to moderate disease. They are used in all stages of dry eye, either alone (in mild to moderate disease) or in combination with other treatments (in moderate to severe disease). Most tear supplements act as lubricants. Other actions may include replacement of deficient tear constituents, dilution of proinflammatory substances, reduction of tear osmolarity and protection against osmotic stress. A wide variety of artificial tear products is currently available. These products differ with respect to several variables, that include electrolyte composition, osmolarity/osmolality, viscosity, the presence or absence of preservatives and the presence or absence of compatible solutes. Although they are all considered as standard of care in treatment of dry eye disease, the effects of many of the available products have not been evaluated in clinical investigations.

Vit-A-Vision is an ointment for ophthalmic application that relieves symptoms such as burning, irritation, slight irritation, dryness or tiredness of the eyes.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vit-A-Vision

Treatment groups

77 Participants
are divided into 1 treatment group

Sponsors and collaborators