Impact of Tixel Treatment on Symptoms and Signs in Patients With Dry Eye Disease (NCT06615453) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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