Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs

Study Overview
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Brief Summary
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Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs

Detailed Description
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Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of treatment on dry eye symptoms and signs through multiple test indicate Dry Eye

Official Title
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Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye

Conditions
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Dry Eye, Dry Eye Syndromes

Intervention / Treatment
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* Device: Tixel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Mild to Moderate Periorbital wrinkles OSDI score of at least 23 Noninvasive Tear film break up time (NIKBUT) ≤ 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. Exclusion Criteria: Pregnancy and/or breastfeeding Lesions in the periorbital area Acute severe blepharitis Acute conjunctivitis 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. Any patient who has a history of bleeding coagulopathies or use of anticoagulants. Any patient who has tattoos or permanent makeup in the treated area. Any patient who has burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated. Any patient who underwent thread lifting of the area to be treated in the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will undergo three sessions of treatments with the Investigation devise
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel Treatment<br>Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 Follow up sessions | Device: Tixel<br>* Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms<br>* Other names: Fractional;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIBUT in Seconds | Non-Invasive Break Up Time | 18 Weeks | 
| Ocular Surface Disease Index questionnaire | Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms. | 18 Weeks | 
| SAFETY, number of AEs | Any safety related event during the study will be recorded and analyzed | 18 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topography mm D | Topography with K readings | 18 Weeks | 
| Slit Lamp Exam; Normal, Abnormal | Multiple Slit Lamp tests | 18 Weeks | 
| Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire | Assessment of the frequency and severity of dry eye symptoms. scored 0 to 28; 0 being no dry eye symptoms and 28 severe dry eye symptoms. | 18 Weeks | 
| Lid margin profile | Lid margin profile | 18 Weeks | 
| Tear Sampling Analysis | ocular tear biomarkers | 18 Weeks | 
| Staining; Total Ocular Staining Score | Corneal staining fluorescein and conjunctival/lid margin staining lissamine green | 18 Weeks |