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Wrinkle fix may soothe dry eyes: new trial launches

NCT ID NCT06615453

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a standard cosmetic treatment for eye wrinkles (Tixel) can also improve symptoms and signs of dry eye disease. 36 adults with mild to moderate wrinkles and dry eyes will receive either real Tixel or a sham treatment. The goal is to see if the treatment is safe and can reduce dry eye discomfort.

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 36 people

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

Started

Sep 2024

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Mild to Moderate Periorbital wrinkles 2. OSDI score of at least 23 3. Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds 4. No other eye or skin or immune problems 5. Willing and able to provide written informed consent. 6. Willing to participate in all study activities and instructions. Exclusion Criteria: 1. Pregnancy and/or breastfeeding 2. Lesions in the periorbital area 3. Acute severe blepharitis 4. Acute conjunctivitis 5. Use of eye drops within 2 hours before examination 6. Other concomitant anterior eye disease 7. Has undergone outdoors/sunbed tanning during the last 4 weeks 8. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments. 9. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously). 10. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area. 11. An impaired immune system condition or use of immunosuppressive medication. 12. Collagen disorders, keloid formation and/or abnormal wound healing. 13. Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel2 device treatment, or before complete healing of such treatments has occurred. 14. Any patient who takes or has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months. 15. Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less. 16. Any patient who has a history of bleeding coagulopathies or use of anticoagulants. 17. Any patient who has tattoos or permanent makeup in the treated area. 18. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated. 19. Any patient who underwent thread lifting of the area to be treated in the last 3 months.

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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

  • Vision Science, School of Optometry

    RECRUITING

    Birmingham, B4 7ET, United Kingdom

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