Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease

NCT06615453 | Recruiting

• 2 other identifiers: HLS21162RECID HLS21162
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease (DED)

Keywords

Dry eye disese, Tixel treatment

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Through study completion, an average of 4 months

Study Arms (2)

Tixel treatment

EXPERIMENTAL

Device: Thermo-mechanical action based peri-orbital fractional skin treatment

Sham treatment

SHAM COMPARATOR

Device: Sham treatment

Interventions

Sham treatment DEVICE

Participants will receive three sham treatments at 2-weeks intervals

Sham treatment

Thermo-mechanical action based peri-orbital fractional skin treatment DEVICE

Participants will receive three Tixel® treatments at 2-weeks intervals

Tixel treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

Vision Science, School of Optometry

Birmingham, B4 7ET, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Sunil Shah, MD

CONTACT

+44 121 711 2020; s.shah26@aston.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

GB (1)