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

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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Device: Tixel

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunil Shah, Phd; Phone Number: +44 121 711 2020; Email: s.shah26@aston.ac.uk

Study Locations

• United Kingdom
  • Solihull, United Kingdom, B91 2AW
    • Recruiting
    • Midland Eye
    • Contact: Sunil Shah, Phd; Phone Number: 0121 667 3251; Email: s.shah26@aston.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aston University
• Investigators: Principal Investigator: Sunil Shah, Phd, Midland Eye

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: UREC 1524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No