A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy … (NCT07059754) | Clinical Trial Compass
RecruitingNot Applicable
A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)
Australia5 participantsStarted 2025-08-25
Plain-language summary
The goal of this clinical trial is to understand what effect a cold treatment with an investigational device, ETX-4143, has on the anatomical structures and the inflammatory response of the surface of the eye in those people who suffer from chronic ocular surface pain (COSP). The trial will also tell us more about the safety of this investigational device. The main questions this study aims to answer are:
* What anatomical changes happen to corneal surface nerves after treatment with ETX-4143
* What changes in inflammatory mediators and cell response take place after treatment with ETX-4143
Researchers will obtain images of the corneal surface nerves for analysis using a confocal microscope and collect tear bio samples for analysis.
Participants will:
* Be screened for having chronic ocular surface pain
* Will be treated with ETX-4143 cold treatment for 4 minutes
* Fill out a weekly questionnaire on eye pain for 12 weeks
* Be seen in the clinic 2 weeks, 6 weeks, and 12 weeks after treatment to have images of the corneal surface taken, and to collect a tear bio sample
Who can participate
Age range
22 Years – 90 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:
* Documented symptoms of COSP pain for at least 3 months
* A score of ≥5 on the single question COP-Q Eye Pain Severity Module
* Able to obtain sufficient quality corneal in-vivo confocal microscopy images
Exclusion Criteria:
* Less than 50% improvement in VAS Eye Pain score after topical 0.5% proparacaine hydrochloride at screening
* Subjects with clinically significant corneal scarring that could limit the confocal microscopy
* Insufficient number of corneal nerves to permit Fun-IVCM imaging
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.
1The EyeCool treatment is being studied for chronic ocular surface pain — can you help me understand whether my specific eye pain diagnosis fits what this trial is targeting, and whether I'd even be a candidate worth discussing with the study team?
2This trial is listed as 'Phase NA,' which often means it's a device or procedure study rather than a traditional drug trial — can you explain what that means for how much safety and effectiveness data already exists for the EyeCool treatment?
3The study is measuring changes to the eye's surface using something called corneal confocal in-vivo microscopy — can you explain what that imaging process involves, how it's done, and whether it carries any risks or discomfort for me?
4Since this trial is specifically looking at surface anatomy and inflammation response rather than directly measuring pain relief, does that mean there's still uncertainty about whether EyeCool actually reduces my pain, and should I consider standard treatments first?
5Are there existing standard-of-care options for chronic ocular surface pain that I should try before considering enrolling in a study like this, or is this trial designed for people who haven't responded to those treatments?
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.