Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease (TIXEL-DED)

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Device: Thermo-mechanical action based peri-orbital fractional skin treatment; Device: Sham treatment

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunil Shah, MD; Phone Number: +44 121 711 2020; Email: s.shah26@aston.ac.uk

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4 7ET
    • Recruiting
    • Vision Science, School of Optometry
    • Contact: Sunil Shah, MD; Phone Number: +44 121 711 2020; Email: s.shah26@aston.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham treatment	Device: Sham treatment; Participants will receive three sham treatments at 2-weeks intervals
Experimental: Tixel treatment	Device: Thermo-mechanical action based peri-orbital fractional skin treatment; Participants will receive three Tixel® treatments at 2-weeks intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Aston University

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dry eye disese, Tixel treatment
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: HLS21162; RECID HLS21162 (Other Identifier: Aston University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No