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

Sponsor
Novoxel Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04260893
Collaborator
(none)
44
Enrollment
1
Location
1
Arm
13.6
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Tixel
N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will undergo three sessions of treatments with the Investigation deviseAll participants will undergo three sessions of treatments with the Investigation devise
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye
Actual Study Start Date :
Jan 23, 2020
Actual Primary Completion Date :
Mar 13, 2021
Actual Study Completion Date :
Mar 13, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Tixel Treatment

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

Device: Tixel
Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
Other Names:
  • Fractional
  • Outcome Measures

    Primary Outcome Measures

    1. SAFETY, number of AEs [8 months]

      Any safety related event during the study will be recorded and analysed

    2. NIBUT in Seconds [8 months]

      Non-Invasive Break Up Time

    3. Ocular Surface Disease Index Questionnaire [8 months]

      OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes

    Secondary Outcome Measures

    1. Topography mm D [8 months]

      Topography with K readings

    2. Staining; Total Ocular Staining Score [8 months]

      Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

    3. Osmolarity mOsml/L [8 months]

      Osmolarity test with TearLab

    4. Slit Lamp Exam; Normal, Abnormal [8 months]

      Multiple Slit Lamp tests

    5. Meibography % [8 months]

      Calculate Meibography using IDRA device

    6. Tear Meniscus Height mm [8 months]

      Tear Meniscus Height using IDRA device

    7. Lid Wiper Epitheliopathy [8 months]

      Lid Wiper Epitheliopathy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Khmer Sight Foundation HospitalPhnom PenhCambodia

    Sponsors and Collaborators

    • Novoxel Ltd.

    Investigators

    • Study Chair: Sunil Shah, MD, University of Puthasastra
    • Principal Investigator: Mukesh Taneja, MD, University of Puthasastra

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novoxel Ltd.
    ClinicalTrials.gov Identifier:
    NCT04260893
    Other Study ID Numbers:
    • CLN 0734
    First Posted:
    Feb 7, 2020
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 7, 2021