Study of the ETX-4143 2.0 Device in Subjects With Eye Pain | NCT06479382

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

NCT06479382

Sponsor

EyeCool Therapeutics, Inc.

Status

Completed

Last Update Posted

Aug 22, 2025Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Eye Pain

Interventions

ETX-4143 2.0

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Nov 29, 2024Actual

Completion Date

Nov 29, 2024Actual

First Submitted Date

Jun 24, 2024

First Submission Date that Met QC Criteria

Jun 24, 2024

First Posted Date

Jun 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational	Experimental	Treatment with the ETX-4143 2.0 device	Device: ETX-4143 2.0
Control	Sham Comparator	Treatment with a sham ETX-4143 2.0 device	Device: ETX-4143 2.0

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ETX-4143 2.0	Device	Treatment of the eye with the ETX-4143 2.0 device	Control Investigational

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Patrick R Casey, OD	VP of Clinical Develpment	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Westmead Hospital		Westmead	New South Wales	2145	Australia
Ophthamic Trials Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42101550	Derived	Galor A, Rapuano C, Epitropoulos A, Weiss J, Pflugfelder S, Gupta P, Dhaliwal D, Periman L, Henderson BA, Nguyen TT, Samarawickrama C, Wu H, Stryjewski T, Stefater JA, Hinds M, Bhindi P, Ifantides C. A Randomized Double-Masked Study Evaluating Safety and Efficacy of a Novel Topical Cooling Device for Chronic Ocular Surface Pain. Ophthalmol Ther. 2026 Jun;15(6):2033-2050. doi: 10.1007/s40123-026-01392-3. Epub 2026 May 8.

ID	Term
D005132	Eye Manifestations
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms