Burning EyeNCT06596733
Vit-A-Vision® Clinical Investigation
A study testing Vit-A-Vision in people with Burning Eye and Irritation; Eyeball, run by OmniVision GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Eye, Irritation; Eyeball, Tired Eye
- What is being tested?
- Vit-A-Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- 19 Dec 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Ophthalmology Cologne Merheim
Cologne, 51109
Norbert Schrage, Prof. Dr., +49 221 8907 13812, schragen@kliniken-koeln.de
About this study
Official title: Clinical Investigation to Evaluate the Efficacy and Safety of Vit-A-Vision® When Used in Dry Eye Disease
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.
- Conditions
- Burning Eye, Irritation; Eyeball, Tired Eye, Dry Eye Disease
- Being tested
- Vit-A-Vision
- Medical subject headings
- Eye Burns, Asthenopia, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit-A-VisionDevice
Participants will apply Vit-A-Vision ointment on a daily basis, up to 3 times daily per eye, for at least 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Vit-A-Vision | Experimental | Application of Vit-A-Vision ointment Receives: Device: Vit-A-Vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 30 days of treatment
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).
Measured: After 30 days of treatment
Secondary outcomes (4)
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.
Measured: After 30 days of treatment
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).
Measured: After 30 days of treatment
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.
Measured: After 30 days of treatment
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.
Measured: After 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Dec 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OmniVision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Schrage, Prof. Dr., Principal investigator, Dept. of Ophthalmology Cologne Merheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596733
- Sponsor's protocol ID
- Vit-A-2023
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Efficacy and Safety of Vit-A-Vision® When Used in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06596733
- Acronym / sponsor ID
- Vit-A-2023
- Conditions
- Burning Eye, Irritation; Eyeball, Tired Eye, Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- OmniVision GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vit-A-Vision | Experimental | Device: Vit-A-VisionApplication of Vit-A-Vision ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit-A-VisionParticipants will apply Vit-A-Vision ointment on a daily basis, up to 3 times daily per eye, for at least 30 days. | Device | Vit-A-Vision |
Primary outcome
Primary Performance - NIBUT
Time frame: After 30 days of treatment
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.
Primary Performance - OSDI
Time frame: After 30 days of treatment
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).
4 secondary outcomes
Secondary Performance - DEQ-5 & symptoms questionnaire
Time frame: After 30 days of treatment
Secondary Performance - ocular surface staining
Time frame: After 30 days of treatment
Secondary Performance - Conjunctival bulbar redness
Time frame: After 30 days of treatment
Secondary Performance - Schirmer test
Time frame: After 30 days of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norbert Schrage, Prof. Dr. principal investigator
Dept. of Ophthalmology Cologne Merheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit-A-Vision in people with Burning Eye and Irritation; Eyeball, run by OmniVision GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joachim Kolter (+49 89 840 792 30, J.Kolter@omnivision.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance - NIBUT (time frame: After 30 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.