Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06615453

Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease

Led by Aston University · Updated on 2026-01-26

36

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will examine how a standard Tixel treatment versus a sham treatment for eye wrinkles affects the symptoms and signs of Dry Eye Disease.

CONDITIONS

Official Title

Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mild to moderate periorbital wrinkles
  • Ocular Surface Disease Index (OSDI) score of at least 23
  • Noninvasive tear film break up time (NIBUT) of 10 seconds or less
  • No other eye, skin, or immune problems
  • Willing and able to provide written informed consent
  • Willing to participate in all study activities and follow instructions
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Lesions in the periorbital area
  • Acute severe blepharitis
  • Acute conjunctivitis
  • Use of eye drops within 2 hours before examination
  • Other concurrent anterior eye diseases
  • Recent outdoors or sunbed tanning in the last 4 weeks
  • Unwillingness to follow Tixel aftercare instructions after treatments
  • Active or history of Herpes Simplex in the periorbital area
  • Current skin cancer, malignant or advanced premalignant lesions or moles in the treatment area
  • Impaired immune system or use of immunosuppressive medication
  • Collagen disorders, keloid formation, or abnormal wound healing
  • Previous invasive or ablative procedures in the treatment areas within 3 months prior or planned during treatment
  • Use of medications, herbal treatments, supplements, or vitamins causing fragile skin or impaired healing within last 3 months
  • Use of oral Isotretinoin within 3 months prior to treatment
  • History of bleeding disorders or use of anticoagulants
  • Tattoos or permanent makeup in the treated area
  • Burned, blistered, irritated, or sensitive skin in the treated areas
  • Thread lifting of the treatment area within last 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vision Science, School of Optometry

Birmingham, United Kingdom, B4 7ET

Actively Recruiting

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Research Team

S

Sunil Shah, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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