Study of the ETX-4143 2.0 Device in Subjects With Eye Pain

A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain

A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects with eye pain

Study Overview

• Status: Completed
• Conditions: Eye Pain
• Intervention / Treatment: Device: ETX-4143 2.0

Detailed Description

A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects who suffer from eye pain an do not get relieve from current medications or clinical treatments. Thirty eyes will be enrolled and randomized 2:1 to the investigational treatment or a sham treatment. Improvement in self-reported ocular pain and clinical safety measures will be evaluated.

It is anticipated that the learnings from the study will be used to design future study of the ETX-4143 2.0 device.

All subjects will be followed for 8 weeks. Subjects will only have the worse eye treated if both eyes meet the inclusion/exclusion criteria.

A medical monitor will evaluate the safety of the study on a continual basis.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4005
      • Ophthamic Trials Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Innovative Eye Care
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Sunshine Eye Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Documented history of eye pain with no relief from currently available medications or treatments
• Willing to forgo participation in any other clinical stud for the duration of this study
• Demonstrate sufficient cognitive awareness to comply with the examination process
• Willing and able to comply with the schedule for follow-up visits
• Willing to participate in the study as evidenced by signing an informed consent document

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
• Any active ocular infection or active ocular inflammation at the time of the screening visit
• History of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, or topical anesthetic abuse
• Any history of significant eye surgery with the prior 90 days
• Planned eye surgery during the entire study
• Participation in any clinical study of an investigational product within 30 days prior to enrollment
• Any history of serious, poorly controlled systemic or ophthalmic condition that could compromise the subject's ability to comply with the protocol or compromise their safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational; Treatment with the ETX-4143 2.0 device	Device: ETX-4143 2.0; Treatment of the eye with the ETX-4143 2.0 device
Sham Comparator: Control; Treatment with a sham ETX-4143 2.0 device	Device: ETX-4143 2.0; Treatment of the eye with the ETX-4143 2.0 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of eye pain	Patient reported level of eye pain	Eight weeks
Adverse events	Adverse events related to treatment	Eight weeks

Collaborators and Investigators

• Sponsor: EyeCool Therapeutics, Inc.
• Investigators: Study Chair: Patrick R Casey, OD, VP of Clinical Develpment

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Eye Diseases; Eye Manifestations; Eye Pain
• Other Study ID Numbers: ETX4143-A002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No