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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Vit-A-Vision
DeviceParticipants will apply Vit-A-Vision ointment on a daily basis, up to 3 times daily per eye, for at least 30 days.
Treatment groups
77 Participants
are divided into 1 treatment groupGroup A: Vit-A-VisionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Performance - NIBUT
Improvements of the Non-Invasive tear film Break Up Time (NIBUT) after 30 days treatment with Vit-A-Vision in comparison to baseline measurements. The NIBUT measurement is an objective measure in seconds, carried out performing a test using a slit lamp.
Time frame
After 30 days of treatment2
Primary Performance - OSDI
Improvements of the Ocular Surface Disease Index (OSDI) after 30 days treatment with Vit-A-Vision in comparison to baseline measurements. The OSDI is calculated using a 12-item questionnaire assessing the frequency of symptoms, environmental triggers and vision related quality of life. The score ranges from 0 (best) to 100 (worst).
Time frame
After 30 days of treatmentSecondary outcomes
1
Secondary Performance - DEQ-5 & symptoms questionnaire
Improvements of the five item Dry Eye Questionnaire (DEQ-5) and symptoms questionnaire after 30 days treatment with Vit-A-Vision in comparison to baseline measurements. The DEQ-5 is a 5 questions questionnaire assessing watery eye, discomfort, dryness, late day discomfort and dryness intensity. The maximum (worst) score is 22. A symptoms questionnaire was added to complement the DEQ-5.
Time frame
After 30 days of treatment2
Secondary Performance - ocular surface staining
Improvements of the ocular surface staining with fluorescein after 30 days treatment with Vit-A-Vision, in comparison to baseline measurements. Conjunctival staining will be graded according to the TFOS (Tear Film and Ocular Surface Society) staining pattern on cornea (5 fields) and conjunctiva (4 field quadrants) using an ocular staining score from 0 (no dots) to 3 (completely spotted).
Time frame
After 30 days of treatment3
Secondary Performance - Conjunctival bulbar redness
Improvements of the conjunctival bulbar redness after 30 days treatment with Vit-A-Vision, in comparison to baseline measurements. Conjunctival bulbar redness data will be collected from photographs, comparing the ones taken before and after use of device and it will be graded with 0 for no difference, 1 for more red, and 2 for less red.
Time frame
After 30 days of treatment4
Secondary Performance - Schirmer test
Improvements of the Schirmer test after 30 days treatment with Vit-A-Vision, in comparison to baseline measurements. The Schirmer test provides an estimation of stimulated reflex tear flow and the normal range is ≧ 10 mm, with lower values corresponding to more severe dry eye disease.
Time frame
After 30 days of treatmentOther outcomes
1
Safety - Adverse Events
Safety of the device will be assessed by systematically reporting any device or procedure related adverse events and serious adverse events (description, severity, relation to the procedure) and by monitoring the frequency and incidence of these events.
Time frame
During the study period (up to 30 days)2
Safety - Device Deficiencies
Safety of the device will be assessed by systematically reporting device deficiencies (description of the deficiency) and by monitoring the frequency and incidence of these events
Time frame
During the study period (up to 30 days)3
Acceptability
Subjective end-user experience after 30 days treatment with Vit-A-Vision using a questionnaire for evaluation of product acceptance and tolerability.
Time frame
After 30 days of treatmentSponsors and contacts
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Source ClinicalTrials.gov