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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an eye drop product called Vit-A-Vision® for dry eye symptoms like burning, irritation, and tired eyes — is this the kind of dry eye condition I have, and does my doctor think it could be a good fit for me to discuss enrolling?
2The trial is measuring something called NIBUT — non-invasive tear break-up time — and also the OSDI questionnaire, which tracks how much dry eye affects my daily life. Can my doctor explain what these measurements mean for understanding whether my eyes are actually improving?
3Since this trial is listed as Phase NA, which often applies to studies on medical devices or already-approved products rather than new drugs, can my doctor explain what that means for how much is already known about the safety of this eye drop?
4The trial is currently recruiting, so if my doctor and I decide it's worth exploring, what does the screening process look like and what would I need to do during the study — like how many visits, how often I'd use the drops, and whether I'd need to stop any current eye treatments?
5Are there standard over-the-counter or prescription dry eye treatments my doctor would recommend trying first, and how does participating in this trial compare to just starting one of those options right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.