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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

Detailed 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

Interventions

  • Device: Tixel
    • Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

Arms, Groups and Cohorts

  • Experimental: Tixel Treatment
    • 3 Tixel treatment sessions, 2 weeks apart follow by 3 Follow up sessions

Clinical Trial Outcome Measures

Primary Measures

  • SAFETY, number of AEs
    • Time Frame: 8 months
    • Any safety related event during the study will be recorded and analysed
  • NIBUT in Seconds
    • Time Frame: 8 months
    • Non-Invasive Break Up Time
  • Ocular Surface Disease Index Questionnaire
    • Time Frame: 8 months
    • OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novoxel Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sunil Shah, MD, Study Chair, University of Puthasastra
    • Mukesh Taneja, MD, Principal Investigator, University of Puthasastra
  • Overall Contact(s)
    • Sharon Naim, B.sc, 00972545500152, sharon@novoxel.com

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