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

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 in Asian Patients.

Detailed Description
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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

Official Title
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A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye

Conditions
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Dry Eye Syndromes, Dry Eye

Intervention / Treatment
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* Device: Tixel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years. 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 follow study instructions. Exclusion Criteria: Pregnancy and/or breastfeeding. Lesions in the periorbital area. Acute severe blepharitis. Acute conjunctivitis. Concomitant anterior eye disease. Has undergone outdoor/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 Tixel treatments, or before complete healing of the treatments has occurred. 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. Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment. History of bleeding coagulopathies or use of anticoagulants. Tattoos or permanent makeup in the areas to be treated. Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated. 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>3 Tixel treatment sessions, 2 weeks apart follow by 3 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 |
| --- | --- | --- |
| SAFETY, number of AEs | Any safety related event during the study will be recorded and analysed | 8 months | 
| NIBUT in Seconds | Non-Invasive Break Up Time | 8 months | 
| Ocular Surface Disease Index Questionnaire | OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topography mm D | Topography with K readings | 8 months | 
| Staining; Total Ocular Staining Score | Corneal staining fluorescein and conjunctival/lid margin staining lissamine green | 8 months | 
| Osmolarity mOsml/L | Osmolarity test with TearLab | 8 months | 
| Slit Lamp Exam; Normal, Abnormal | Multiple Slit Lamp tests | 8 months | 
| Meibography % | Calculate Meibography using IDRA device | 8 months | 
| Tear Meniscus Height mm | Tear Meniscus Height using IDRA device | 8 months | 
| Lid Wiper Epitheliopathy | Lid Wiper Epitheliopathy | 8 months |