Vitamin A–based eye ointment for dry, burning, or irritated eyes
Official title: Clinical Investigation to Evaluate the Efficacy and Safety of Vit-A-Vision® When Used in Dry Eye Disease
Run by OmniVision GmbH · NCT06596733 · Data updated 2026-11-12
This trial will try a vitamin A–based ointment called Vit-A-Vision in adults with dry eye symptoms to see if it improves comfort and tear stability.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 77 (estimated) |
| Sponsor | OmniVision GmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Cologne) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT06596733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with symptomatic dry eye (OSDI ≥16) and a median NIBUT ≤10 seconds who are willing to use the product as directed, stop contact lens wear, and attend two follow-up visits are ideal candidates.
✕Probably not a fit
People with severe dry eye (OSDI >55), known allergy to any ingredient, recent ocular surgery, or unwillingness to discontinue contact lens use are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an interventional, single-center study of a topical vitamin A ointment (Vit-A-Vision) applied by participants according to the instructions for use over about 33 days, with visits at baseline, day 15, and day 33. Eligible adults have symptomatic mild-to-moderate dry eye (OSDI ≥16 and median NIBUT ≤10 seconds in at least one eye) and must agree to stop contact lens wear during the study. Key exclusions include severe dry eye (OSDI >55), known allergy to product ingredients, and recent ocular surgery. Outcomes focus on symptom scores and tear-film break-up time to determine short-term tolerability and symptomatic effect.
Why it matters
Potential benefit: If successful, the ointment could provide improved lubrication and symptom relief for people with mild-to-moderate dry eye, making daily tasks like reading and screen use more comfortable.
How similar studies have gone: Topical formulations containing vitamin A derivatives have shown symptomatic benefit in some smaller studies and clinical practice, but high-quality randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dept. of Ophthalmology Cologne Merheim
Cologne, Germany Recruiting
Study contacts
- Principal investigator: Norbert Schrage, Prof. Dr. — Dept. of Ophthalmology Cologne Merheim
- Study coordinator: Joachim Kolter
- Email: J.Kolter@omnivision.de
- Phone: +49 89 840 792 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.