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 | Active Not Recruiting DMC

• 1 other identifier: ETX4143-A005
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Ocular Surface Pain; Ophthalmic Cooling; Topical Ophthalmic Cooling; Cooling Device; Ocular Surface

Outcome Measures

Primary Outcomes (1)

• Corneal Confocal In-vivo Microscopy Image Analysis

  Non-invasive imaging of the corneal surface for assessing ocular tissue structure.

  From treatment to the end of twelve weeks

Study Arms (1)

Interventional

EXPERIMENTAL

Eyes that are treated with the ETX-4143 topical ophthalmic cooling device

Device: Topical Ophthalmic Cooling

Interventions

Topical Ophthalmic Cooling DEVICE

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

Interventional

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeCool Therapeutics, Inc.: lead

Study Sites (1)

Sunshine Eye Surgeons

Melbourne, Victoria, 3021, Australia

Location

Related Publications (1)

• Galor A, Hamrah P, Haque S, Attal N, Labetoulle M. Understanding chronic ocular surface pain: An unmet need for targeted drug therapy. Ocul Surf. 2022 Oct;26:148-156. doi: 10.1016/j.jtos.2022.08.005. Epub 2022 Aug 13.

  PMID: 35970433 BACKGROUND

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Patrick Casey R VP of Clinical Development, Optometrist

  EyeCool Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: July 11, 2025
• Study Start: August 25, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)