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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tixel treatment

Group Type EXPERIMENTAL

Thermo-mechanical action based peri-orbital fractional skin treatment

Intervention Type DEVICE

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

Sham treatment

Group Type SHAM_COMPARATOR

Sham treatment

Intervention Type DEVICE

Participants will receive three sham treatments at 2-weeks intervals

Interventions

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Thermo-mechanical action based peri-orbital fractional skin treatment

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

Intervention Type DEVICE

Sham treatment

Participants will receive three sham treatments at 2-weeks intervals

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No