RecruitingNot Applicable

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

United Kingdom36 participantsStarted 2024-09-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Mild to Moderate Periorbital wrinkles
✓. OSDI score of at least 23
✓. Noninvasive Tear film break up time (NIBUT) ≤ 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
✕. Use of eye drops within 2 hours before examination
✕. 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.

What they're measuring

To assess the safety of periorbital Tixel treatments in patients with dry eye through the reporting of adverse events (AE) and serious adverse events (SAE) exclusively.

Timeframe: Through study completion, an average of 4 months

Trial details

NCT IDNCT06615453

SponsorAston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

Contact for this trial

Sunil Shah, MD

+44 121 711 2020 s.shah26@aston.ac.uk

View on ClinicalTrials.gov More Dry Eye Disease (DED) trials