Tixel treatment for symptoms of dry eye disease

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 is testing if Tixel treatment can help people with dry eye disease feel better compared to a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aston University (Academic / other)
• Locations: 1 site (Birmingham)
• Trial ID: NCT06615453 on ClinicalTrials.gov

What this trial studies

This study examines the effects of Tixel treatment, a thermo-mechanical action based peri-orbital fractional skin treatment, compared to a sham treatment on patients with Dry Eye Disease. Participants will be assessed for symptoms and signs of the condition, focusing on those with mild to moderate periorbital wrinkles and specific eye health criteria. The study aims to determine if Tixel treatment can provide significant relief from dry eye symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals with mild to moderate periorbital wrinkles and a specific score indicating dry eye symptoms.

Not a fit: Patients with severe eye conditions or those currently using eye drops may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of dry eye disease for patients.

How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in treating related conditions.

Eligibility criteria

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.

Where this trial is running

Birmingham

• Vision Science, School of Optometry — Birmingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Sunil Shah, MD

Conditions Dry Eye Disease; Dry eye disese, Tixel treatment