Clinical Trial

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)

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated May 26, 2026 (before its estimated July 15, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 3 changes
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-05-27
notable Primary completion pushed: 2026-03-15 -> 2026-07-15 2026-05-27
minor Completion pushed: 2026-03-15 -> 2026-07-15 2026-05-27
Trial Details
NCT Number NCT07059754
Lead Sponsor EyeCool Therapeutics, Inc.
Conditions Eye Pain
Enrollment 5 participants
Start Date 2025-08-25
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-26