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

Sponsor
Aston University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04730336
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
28.7
Anticipated Duration (Months)
2.6
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

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 treatment on dry eye symptoms and signs through multiple test indicate Dry Eye

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 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:
Assessment of the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs in Patients With Dry Eye
Actual Study Start Date :
Aug 9, 2019
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Tixel Treatment

Tixel Treatment 3 Tixel treatment sessions, 2 weeks apart follow by 2 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. NIBUT in Seconds [18 Weeks]

      Non-Invasive Break Up Time

    2. Ocular Surface Disease Index questionnaire [18 Weeks]

      Total 12 questions will be asked, ranked between 0-100. 0 being no dry eye symptoms and 100 severe dry eye symptoms.

    3. SAFETY, number of AEs [18 Weeks]

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

    Secondary Outcome Measures

    1. Topography mm D [18 Weeks]

      Topography with K readings

    2. Slit Lamp Exam; Normal, Abnormal [18 Weeks]

      Multiple Slit Lamp tests

    3. Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire [18 Weeks]

      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.

    4. Lid margin profile [18 Weeks]

      Lid margin profile

    5. Tear Sampling Analysis [18 Weeks]

      ocular tear biomarkers

    6. Staining; Total Ocular Staining Score [18 Weeks]

      Corneal staining fluorescein and conjunctival/lid margin staining lissamine green

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Midland EyeSolihullUnited KingdomB91 2AW

    Sponsors and Collaborators

    • Aston University

    Investigators

    • Principal Investigator: Sunil Shah, Phd, Midland Eye

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aston University
    ClinicalTrials.gov Identifier:
    NCT04730336
    Other Study ID Numbers:
    • UREC 1524
    First Posted:
    Jan 29, 2021
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2021