Dry Eye Disease (DED)TIXEL-DEDNCT06615453
Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease
A study testing Thermo-mechanical action based peri-orbital fractional skin treatment in people with Dry Eye Disease (DED), run by Aston University at 1 site in United Kingdom.
Trial summary
This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Thermo-mechanical action based peri-orbital fractional skin treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2024to 31 Jul 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
- Mild to Moderate Periorbital wrinkles
- OSDI score of at least 23
- Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds
- No other eye or skin or immune problems
- Willing and able to provide written informed consent.
- Willing to participate in all study activities and instructions.
Who cannot join
- Pregnancy and/or breastfeeding
- Lesions in the periorbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Use of eye drops within 2 hours before examination
- Other concomitant anterior eye disease
Show all 19Show fewer
- Has undergone outdoors/sunbed tanning during the last 4 weeks
- Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
- Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
- Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- An impaired immune system condition or use of immunosuppressive medication.
- Collagen disorders, keloid formation and/or abnormal wound healing.
- 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.
- 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.
- Any patient who has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment or less.
- Any patient who has a history of bleeding coagulopathies or use of anticoagulants.
- Any patient who has tattoos or permanent makeup in the treated area.
- Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- Any patient who underwent thread lifting of the area to be treated in the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Vision Science, School of Optometry
Birmingham, B4 7ET
Sunil Shah, MD, +44 121 711 2020, s.shah26@aston.ac.uk
About this study
Official title: A Prospective Study Assessing the Impact of Tixel Treatment of Peri Orbital Wrinkles on Symptoms and Signs in Patients With Dry Eye Disease
This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Thermo-mechanical action based peri-orbital fractional skin treatment, Sham treatment
- Keywords
- Dry eye disese, Tixel treatment
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermo-mechanical action based peri-orbital fractional skin treatmentDevice
Participants will receive three Tixel® treatments at 2-weeks intervals
Sham treatmentDevice
Participants will receive three sham treatments at 2-weeks intervals
| Study group | Role | What they receive |
|---|---|---|
| Tixel treatment | Experimental | Not described Receives: Device: Thermo-mechanical action based peri-orbital fractional skin treatment |
| Sham treatment | Sham comparator | Not described Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed
Measured: Through study completion, an average of 4 months
Secondary outcomes (1)
To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.
NIBUT Seconds OSDI Score Topography mm/ D Slit Lamp examination Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Lid margin profile Tear Sampling Analysis Ocular tear biomarkers Meibography Corneal staining with fluorescein Conjunctival staining with lissamine green
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start17 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615453
- Sponsor's protocol ID
- HLS21162
- Other IDs
- RECID HLS21162
- Acronym
- TIXEL-DED
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Assessing the Impact of Tixel Treatment of Peri Orbital Wrinkles on Symptoms and Signs in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06615453
- Acronym / sponsor ID
- TIXEL-DED / HLS21162
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry eye disese, Tixel treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 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.
This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tixel treatment | Experimental | Device: Thermo-mechanical action based peri-orbital fractional skin treatment |
| Sham treatment | Sham comparator | Device: Sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mild to Moderate Periorbital wrinkles
- OSDI score of at least 23
- Noninvasive Tear film break up time (NIBUT) ≤ 10 seconds
- No other eye or skin or immune problems
- Willing and able to provide written informed consent.
Key exclusion criteria (19 listed)
- Pregnancy and/or breastfeeding
- Lesions in the periorbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Use of eye drops within 2 hours before examination
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 |
|---|---|---|
| Thermo-mechanical action based peri-orbital fractional skin treatmentParticipants will receive three Tixel® treatments at 2-weeks intervals | Device | Tixel treatment |
| Sham treatmentParticipants will receive three sham treatments at 2-weeks intervals | Device | Sham treatment |
Primary outcome
To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.
Time frame: Through study completion, an average of 4 months
SAFETY, number of AEs Any safety related event during the study will be recorded and analyzed
1 secondary outcome
To evaluate the impact of the treatment on symptoms and signs of dry eyes and compare the findings with those of a control group.
Time frame: Through study completion, an average of 4 months
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 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermo-mechanical action based peri-orbital fractional skin treatment in people with Dry Eye Disease (DED), run by Aston University at 1 site in United Kingdom.
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 19 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 26 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 Sunil Shah, MD (+44 121 711 2020, s.shah26@aston.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively. (time frame: Through study completion, an average of 4 months). 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 26 Jan 2026.