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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)

RecruitingNAAges 22 Years - 90 YearsAllEyeCool Therapeutics, Inc.
NCT07059754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Topical Ophthalmic Cooling
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Where

1 site
Sunshine Eye Surgeons
Melbourne, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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