Wrinkle fix may soothe dry eyes: new trial launches
NCT ID NCT06615453
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Vision Science, School of Optometry
RECRUITINGBirmingham, B4 7ET, United Kingdom
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