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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)

StatusRecruiting
PhaseNot applicable
Started
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.

Record History

  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Primary and study completion pushed from Mar 15, 2026 to Jul 15, 2026
    • Site details revised
    v3
  2. Trial status: Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Nov 15, 2025 to Mar 15, 2026
    • Study completion date: Dec 15, 2025 to Mar 15, 2026
    • Start date changed from estimate of Aug 15, 2025 to Aug 25, 2025
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07059754
Lead Sponsor EyeCool Therapeutics, Inc.
Conditions
(from sponsor)		 Eye Pain
Related terms Eye Pain
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov