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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07059754




Registration number
NCT07059754
Ethics application status
Date submitted
29/03/2025
Date registered
11/07/2025
Date last updated
11/07/2025

Titles & IDs
Public title
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)
Scientific title
A Prospective, Feasibility, Single-Center, Clinical Study to Evaluate the Effect of the ETX-4143 Topical Ophthalmic Cooling Device on Ocular Surface Structures and Cell Population in Patients With Chronic Ocular Surface Pain
Secondary ID [1] 0 0
ETX4143-A005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eye Pain 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Topical Ophthalmic Cooling

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


Treatment: Devices: Topical Ophthalmic Cooling
Targeted topical ophthalmic cooling treatment using the ETX-4143 cooling device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Corneal Confocal In-vivo Microscopy Image Analysis
Timepoint [1] 0 0
From treatment to the end of twelve weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
22 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Sunshine Eye Surgeons - Melbourne
Recruitment postcode(s) [1] 0 0
3021 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EyeCool Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Casey R VP of Clinical Development, Optometrist
Address 0 0
EyeCool Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Patrick Casey, Optometrist
Address 0 0
Country 0 0
Phone 0 0
15104100543
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07059754