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

NCT04730336 | Completed

• 1 other identifier: UREC 1524
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Topography mm D

  18 Weeks

• Slit Lamp Exam; Normal, Abnormal

  18 Weeks

• Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire

  18 Weeks

• Lid margin profile

  18 Weeks

• Tear Sampling Analysis

  18 Weeks

Study Arms (1)

Tixel Treatment

EXPERIMENTAL

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

Device: Tixel

Interventions

Tixel DEVICE

Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms

Also known as: Fractional

Tixel Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

Midland Eye

Solihull, B91 2AW, United Kingdom

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sunil Shah, Phd

  Midland Eye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo three sessions of treatments with the Investigation devise

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: August 9, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)