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New treatment option for Burning Eye
Official title Vit-A-Vision® Clinical Investigation
ClinicalTrials.gov ID: NCT06596733
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Known hypersensitivity (allergy) to any of the ingredients of Vit-A-Vision: vaseline, paraffin, adeps lanae, vitamin A palmitate, dexpanthenol...
- 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...
- 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...
See the full eligibility 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
- 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...
- Individuals who are deprived of liberty pursuant to an administrative order or court order or approval
The study team makes the final eligibility decision.
Where it's taking place
- Cologne, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cologne, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.