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New eye ointment aims to soothe dry, burning eyes

NCT ID NCT06596733

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether Vit-A-Vision, an eye ointment used up to three times daily, can improve dry eye symptoms like burning and irritation. About 77 adults with dry eye disease will use the ointment for 30 days. Researchers will measure tear film stability and symptom scores to see if the product provides relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vit-A-Vision ointment (a lubricating eye ointment)
What this could lead to
If it works, this could provide a new over-the-counter option to relieve dry eye symptoms like burning and irritation.
What could go wrong
This is a small, early-stage trial with no comparison group, so results may not be conclusive. The ointment may not work for everyone, and side effects could include temporary blurred vision.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 77 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dept. of Ophthalmology Cologne Merheim

    RECRUITING

    Cologne, 51109, Germany

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