Eye PainNCT07059754
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)
A study testing Topical Ophthalmic Cooling in people with Eye Pain, run by EyeCool Therapeutics, Inc. at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 90 years
- Conditions the study is for
- Eye Pain
- What is being tested?
- Topical Ophthalmic Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Aug 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristos Ifantides A Prospective, Feasibility, Single-Center, Clinical Study to E contact
Australia1 site, 1 recruiting
- Recruiting
Sunshine Eye Surgeons
Melbourne, Victoria, 3021
Rachel McIntosh Managing Director, MPH, +61 0402 133 315, rlm@zave.com.au
About this study
Official 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
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
Read more
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
Read the detailed description
EyeCool Therapeutics was founded on the hypothesis that a mild ocular surface cooling treatment, delivered through its proprietary cooling device (ETX-4143), can improve the symptoms of chronic ocular surface pain by transiently inhibiting nerve signaling, and potentially reducing ocular surface inflammation, and potentially restoring normal ocular surface nerve function.
The ETX-4143 Device is a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol. The ETX-4143 Device does not contain an active pharmaceutical ingredient. The frozen mixture internally cools two metallic probes that contact the conjunctival surface of the patient; there is no direct contact of the ocular surface with the frozen mixture. Prior to placement of the device on the ocular surface, local anesthesia is administered and a custom speculum used to open and insulate the eyelids, as well as promote correct positioning of the Device. A cornea shield is applied to maintain corneal wetness during the procedure. The Device and accessory (speculum) are provided in disposable, single-use packaging.
In this prospective, single-center, single-center clinical study, 5 adult subjects with chronic ocular surface pain will be identified and treated with the ETX-4143 Device (Cooling Device for topical ophthalmic use). The main goal of the study is to further evaluate the device for changes in ocular surface components using in vivo confocal microscopy, and for safety and efficacy. Improvement in self-reported ocular discomfort and clinical safety measures will be evaluated, along with in vivo confocal microscopy of the cornea before and after treatment.
It is anticipated that the learnings from these observations will be used to design future studies of the ETX-4143 device. In this study, five subjects will receive the investigational product (ETX-4143 Device).
The Medical Monitor will evaluate the clinical safety data as it becomes available and no less than on at least a quarterly basis.
All subjects will be followed for a total of 12 weeks. Subjects will have only the worse eye treated, if both eyes meet the inclusion/exclusion criteria. The worse eye will be determined by the investigator based on subjective reporting from the study subject of chronic ocular surface pain and/or other screening assessments in each eye. Both eyes will be assessed for tear osmolarity and imaged using corneal in vivo confocal microscopy at the University of Melbourne, with the untreated eye representing a control.
- Conditions
- Eye Pain
- Being tested
- Topical Ophthalmic Cooling
- Keywords
- Chronic Ocular Surface Pain, Ophthalmic Cooling, Topical Ophthalmic Cooling, Cooling Device, Ocular Surface
- Medical subject headings
- Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ophthalmic CoolingDevice
Targeted topical ophthalmic cooling treatment using the ETX-4143 cooling device
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Eyes that are treated with the ETX-4143 topical ophthalmic cooling device Receives: Device: Topical Ophthalmic Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Confocal In-vivo Microscopy Image Analysis
Non-invasive imaging of the corneal surface for assessing ocular tissue structure.
Measured: From treatment to the end of twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start25 Aug 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eye PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EyeCool Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Casey R VP of Clinical Development, Optometrist, Study chair, EyeCool Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059754
- Sponsor's protocol ID
- ETX4143-A005
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35970433Chiang JCB, Wu M, Lee JH, Curkpatrick A, Ifantides C, Nguyen T, Galor A, Wu H, Lindstrom R, Thompson V, Downie LE. Impact of an Ophthalmic Cooling Device on Corneal Immune and Sensory Nerve Features in Chronic Ocular Surface Pain: A Prospective, Feasibility Study. Ophthalmol Ther. 2026 Jul 15. doi: 10.1007/s40123-026-01454-6. Online ahead of print.
PubMed 42455250
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07059754
- Acronym / sponsor ID
- ETX4143-A005
- Conditions
- Eye Pain
- Keywords
- Chronic Ocular Surface Pain, Ophthalmic Cooling, Topical Ophthalmic Cooling, Cooling Device, Ocular Surface
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- EyeCool Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
EyeCool Therapeutics was founded on the hypothesis that a mild ocular surface cooling treatment, delivered through its proprietary cooling device (ETX-4143), can improve the symptoms of chronic ocular surface pain by transiently inhibiting nerve signaling, and potentially reducing ocular surface inflammation, and potentially restoring normal ocular surface nerve function.
The ETX-4143 Device is a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol. The ETX-4143 Device does not contain an active pharmaceutical ingredient. The frozen mixture internally cools two metallic probes that contact the conjunctival surface of the patient; there is no direct contact of the ocular surface with the frozen mixture. Prior to placement of the device on the ocular surface, local anesthesia is administered and a custom speculum used to open and insulate the eyelids, as well as promote correct positioning of the Device. A cornea shield is applied to maintain corneal wetness during the procedure. The Device and accessory (speculum) are provided in disposable, single-use packaging.
In this prospective, single-center, single-center clinical study, 5 adult subjects with chronic ocular surface pain will be identified and treated with the ETX-4143 Device (Cooling Device for topical ophthalmic use). The main goal of the study is to further evaluate the device for changes in ocular surface components using in vivo confocal microscopy, and for safety and efficacy. Improvement in self-reported ocular discomfort and clinical safety measures will be evaluated, along with in vivo confocal microscopy of the cornea before and after treatment.
It is anticipated that the learnings from these observations will be used to design future studies of the ETX-4143 device. In this study, five subjects will receive the investigational product (ETX-4143 Device).
The Medical Monitor will evaluate the clinical safety data as it becomes available and no less than on at least a quarterly basis.
All subjects will be followed for a total of 12 weeks. Subjects will have only the worse eye treated, if both eyes meet the inclusion/exclusion criteria. The worse eye will be determined by the investigator based on subjective reporting from the study subject of chronic ocular surface pain and/or other screening assessments in each eye. Both eyes will be assessed for tear osmolarity and imaged using corneal in vivo confocal microscopy at the University of Melbourne, with the untreated eye representing a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Topical Ophthalmic CoolingEyes that are treated with the ETX-4143 topical ophthalmic cooling device |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Ophthalmic CoolingTargeted topical ophthalmic cooling treatment using the ETX-4143 cooling device | Device | Interventional |
Primary outcome
Corneal Confocal In-vivo Microscopy Image Analysis
Time frame: From treatment to the end of twelve weeks
Non-invasive imaging of the corneal surface for assessing ocular tissue structure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 35970433Galor 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.
- Derived from this study: PubMed 42455250Chiang JCB, Wu M, Lee JH, Curkpatrick A, Ifantides C, Nguyen T, Galor A, Wu H, Lindstrom R, Thompson V, Downie LE. Impact of an Ophthalmic Cooling Device on Corneal Immune and Sensory Nerve Features in Chronic Ocular Surface Pain: A Prospective, Feasibility Study. Ophthalmol Ther. 2026 Jul 15. doi: 10.1007/s40123-026-01454-6. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristos Ifantides A Prospective, Feasibility, Single-Center, Clinical Study to E contact
Patrick Casey R VP of Clinical Development, Optometrist study chair
EyeCool Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Ophthalmic Cooling in people with Eye Pain, run by EyeCool Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Casey, Optometrist (15104100543, patrick.casey@eyecooltx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Confocal In-vivo Microscopy Image Analysis (time frame: From treatment to the end of twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07059754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.