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RecruitingNAINTERVENTIONAL

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

This research is investigating whether a skin treatment called Tixel, which is typically used to improve eye wrinkles, can also help people who suffer from dry eyes. Participants will either receive the Tixel treatment or a 'sham' (dummy) treatment, which looks like the real thing but has no active effect. The study aims to measure popular dry eye symptoms and physical signs to see if the Tixel treatment makes a difference. If successful, this could offer a new way to help manage dry eye disease, which can be very uncomfortable for many people. It's about finding out if there's an unexpected benefit to this existing treatment.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Aston University
Enrolment target
36
Start
17 Sep 2024
Estimated completion
31 Jul 2026

What is this study about?

This study is designed to explore whether a beauty treatment called Tixel, which uses heat to improve skin around the eyes, could also help people with dry eyes. Dry eye disease is a common condition where your eyes don't make enough tears, or the tears evaporate too quickly, leading to discomfort, blurry vision, and irritation. While Tixel is usually used for wrinkles, researchers want to see if it has an additional benefit for dry eye symptoms.

Participants in the study will be divided into two groups. One group will receive the actual Tixel treatment, while the other group will receive a 'sham' treatment. A sham treatment looks and feels similar to the real one, but it doesn't have the active component. This helps researchers figure out if any improvements seen are truly due to the Tixel treatment or just a placebo effect or natural variation.

The main goal is to compare how often dry eye symptoms occur and their severity, as well as checking physical signs of dry eye in both groups. By doing this, the researchers hope to understand if Tixel could become a new option for managing dry eye disease for some individuals.

Key takeaways

  • This study explores a potential new use for an existing skin treatment.
  • It compares Tixel treatment to a 'dummy' treatment for dry eyes.
  • Participants must have both dry eyes and mild eye wrinkles.
  • Careful skin aftercare is required for those receiving treatment.
  • Many health conditions or recent treatments could prevent participation.

Who may be eligible?

To be part of this study, you need to be an adult (18 or older) and have mild to moderate dry eye symptoms that bother you. You should also have some mild to moderate wrinkles around your eyes, as the Tixel treatment is applied to this area. Your eyes should not have any other serious problems, and you shouldn't have any major ongoing health conditions.

There are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have certain skin conditions, active infections around your eyes (like eyelid inflammation or conjunctivitis), or a history of cold sores in the treated area. The study also cannot include anyone who has recently had significant sun exposure or other cosmetic procedures around the eyes.

It's important that you haven't used certain medications or herbal treatments that affect skin healing in the last three months. If you have tattoos or permanent makeup in the area to be treated, or very sensitive/damaged skin, you also wouldn't qualify. The research team needs to make sure it's safe for everyone involved and that the results of the treatment can be clearly seen.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have dry eye symptoms that bother you?
  3. Do you have some mild to moderate wrinkles around your eyes?
  4. Are you able to attend all study appointments?
  5. Are you currently not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have specific appointments to attend. You will be given either the active Tixel treatment or a sham treatment around your eyes. This will involve several treatment sessions over a period. Doctors and nurses will examine your eyes and ask you questions about your dry eye symptoms at each visit.

Before and after treatments, your tear film (the liquid coating your eye) will be checked. You'll also be asked to follow specific instructions for caring for your skin after each treatment. The research team will explain how long you will need to participate and exactly what is expected from you at each stage. It's important to attend all scheduled visits and follow all instructions carefully to ensure the study results are accurate.

Potential risks and benefits

Participating in research can sometimes offer a potential benefit if the treatment works, but there's no guarantee. You might find your dry eye symptoms improve, even with the sham treatment. However, there are potential risks, like temporary skin redness, swelling, or discomfort from the treatment itself. The research team will explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Vision Science, School of Optometry
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is Tixel treatment?

Tixel is a treatment that uses heat to help improve the skin, often used for wrinkles around the eyes.

Will I know if I'm getting the real treatment or the dummy treatment?

No, to ensure fair results, you won't know if you're getting the active Tixel treatment or the sham (dummy) treatment.

Can I still use my usual eye drops during the study?

You will get specific instructions about eye drop use, especially within two hours before examinations. You may need to adjust your routine.

What happens if I get cold sores often?

If you have a history of cold sores around your eyes, you may not be able to join this study due to potential risks from the treatment.

Is there a limit on how old I can be to join?

No, as long as you are 18 years or older, there is no upper age limit for this study.

How to find out more

Sunil Shah, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of Tixel Treatment on Symptoms and Signs in Patients …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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