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)
RecruitingNot applicableNCT07059754
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- A Prospective, Feasibility, Single-Center, Clinical Study to Evaluate the Effect of the ETX-4143 Topical Ophthalmic Cooling Device on Ocular Surface Structures and Cell Population in Patients With Chronic Ocular Surface Pain
- Conditions
- Eye Pain
- Interventions
- Device: Topical Ophthalmic Cooling
- Sponsor
- EyeCool Therapeutics, Inc.
- Start date
- 2025-08-25
- Primary completion
- 2026-07-15
- Sex
- All
- Age range
- from 22 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07059754