Dry EyeNCT04730336
Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs
A study testing Tixel in people with Dry Eye and Dry Eye Syndromes, run by Aston University at 1 site in United Kingdom.
Trial summary
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- Tixel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Aug 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Mild to Moderate Periorbital wrinkles
- OSDI score of at least 23
- Noninvasive Tear film break up time (NIKBUT) ≤ 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
- Other concomitant anterior eye disease
- Has undergone outdoors/sunbed tanning during the last 4 weeks
Show all 18Show fewer
- 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.
About this study
Official title: Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
Read the detailed description
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Tixel
- 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.
TixelDevice
Also called Fractional
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
| Study group | Role | What they receive |
|---|---|---|
| Tixel Treatment | Experimental | Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions Receives: Device: Tixel |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIBUT in Seconds
Non-Invasive Break Up Time
Measured: 18 Weeks
Ocular Surface Disease Index questionnaire
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
Measured: 18 Weeks
SAFETY, number of AEs
Any safety related event during the study will be recorded and analyzed
Measured: 18 Weeks
Secondary outcomes (6)
Topography mm D
Topography with K readings
Measured: 18 Weeks
Slit Lamp Exam; Normal, Abnormal
Multiple Slit Lamp tests
Measured: 18 Weeks
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms.
Measured: 18 Weeks
Lid margin profile
Lid margin profile
Measured: 18 Weeks
Tear Sampling Analysis
ocular tear biomarkers
Measured: 18 Weeks
Staining; Total Ocular Staining Score
Corneal staining fluorescein and conjunctival/lid margin staining lissamine green
Measured: 18 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start9 Aug 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo three sessions of treatments with the Investigation devise
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Shah, Phd, Principal investigator, Midland Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730336
- Sponsor's protocol ID
- UREC 1524
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT04730336
- Acronym / sponsor ID
- UREC 1524
- Conditions
- Dry Eye, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 29 Jan 2021 (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.
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs
Detailed description
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo three sessions of treatments with the Investigation devise
| Arm | Type | Receives |
|---|---|---|
| Tixel Treatment | Experimental | Device: TixelTixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Mild to Moderate Periorbital wrinkles
- OSDI score of at least 23
- Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds
- No other eye or skin or immune problems
Key exclusion criteria (18 listed)
- Pregnancy and/or breastfeeding
- Lesions in the periorbital area
- Acute severe blepharitis
- Acute conjunctivitis
- Other concomitant anterior eye disease
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 |
|---|---|---|
| TixelAlso: FractionalPeri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms | Device | Tixel Treatment |
Primary outcome
NIBUT in Seconds
Time frame: 18 Weeks
Non-Invasive Break Up Time
Ocular Surface Disease Index questionnaire
Time frame: 18 Weeks
Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.
SAFETY, number of AEs
Time frame: 18 Weeks
Any safety related event during the study will be recorded and analyzed
6 secondary outcomes
Topography mm D
Time frame: 18 Weeks
Slit Lamp Exam; Normal, Abnormal
Time frame: 18 Weeks
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Time frame: 18 Weeks
Lid margin profile
Time frame: 18 Weeks
Tear Sampling Analysis
Time frame: 18 Weeks
Staining; Total Ocular Staining Score
Time frame: 18 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sunil Shah, Phd principal investigator
Midland Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tixel in people with Dry Eye and Dry Eye Syndromes, 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 27 Mar 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIBUT in Seconds (time frame: 18 Weeks). The study lists 3 primary outcomes in all. 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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.