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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)

NCT07059754 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-01-08

No results posted yet for this study

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

Conditions

  • Eye Pain

Interventions

DEVICE

Topical Ophthalmic Cooling

Targeted topical ophthalmic cooling treatment using the ETX-4143 cooling device

Sponsors & Collaborators

  • EyeCool Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Casey R VP of Clinical Development, Optometrist · EyeCool Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-03-15
Completion
2026-03-15

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059754 on ClinicalTrials.gov