Prospective Study To Assess The Safety And Effectiveness Of Tixel Treatment On Dry Eye Symptoms In Asian Patients (DED)

Novoxel

Status: Terminated

Conditions: Dry Eye; Dry Eye Syndromes

Treatments: Device: Tixel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04260893

CLN 0734

Details and patient eligibility

About

Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs in Asian Patients.

Full description

Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of the treatment on dry eye symptoms and signs through multiple

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years.
2. OSDI score of at least 23.
3. Noninvasive Tear film break up time (NIKBUT) ≤ 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 follow study instructions.

Exclusion criteria

1. Pregnancy and/or breastfeeding.
2. Lesions in the periorbital area.
3. Acute severe blepharitis.
4. Acute conjunctivitis.
5. Concomitant anterior eye disease.
6. Has undergone outdoor/sunbed tanning during the last 4 weeks.
7. Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
8. Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
9. Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
10. An impaired immune system condition or use of immunosuppressive medication.
11. Collagen disorders, keloid formation and/or abnormal wound healing.
12. 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 Tixel treatments, or before complete healing of the treatments has occurred.
13. 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.
14. Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
15. History of bleeding coagulopathies or use of anticoagulants.
16. Tattoos or permanent makeup in the areas to be treated.
17. Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
18. Thread lifting of the area to be treated in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Tixel Treatment

Experimental group

Description:

3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions

Treatment:

Device: Tixel