Eye PainNCT06479382
Study of the ETX-4143 2.0 Device in Subjects With Eye Pain
A study testing ETX-4143 2.0 in people with Eye Pain, run by EyeCool Therapeutics, Inc. at 4 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Pain
- What is being tested?
- ETX-4143 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 4 sitesAustralia
- Study dates
- 1 Aug 2024to 29 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Innovative Eye Care
Adelaide, South Australia, 5000
Ophthamic Trials Australia
Brisbane, Queensland, 4005
Sunshine Eye Surgeons
St Albans, Victoria, 3021
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official title: 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
Read the 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.
- Conditions
- Eye Pain
- Being tested
- ETX-4143 2.0
- Medical subject headings
- Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETX-4143 2.0Device
Treatment of the eye with the ETX-4143 2.0 device
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Treatment with the ETX-4143 2.0 device Receives: Device: ETX-4143 2.0 |
| Control | Sham comparator | Treatment with a sham ETX-4143 2.0 device Receives: Device: ETX-4143 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of eye pain
Patient reported level of eye pain
Measured: Eight weeks
Adverse events
Adverse events related to treatment
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Aug 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeCool Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick R Casey, OD, Study chair, VP of Clinical Develpment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479382
- Sponsor's protocol ID
- ETX4143-A002
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42101550
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain
- ClinicalTrials.gov ID
- NCT06479382
- Acronym / sponsor ID
- ETX4143-A002
- Conditions
- Eye Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- EyeCool Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 28 Jun 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: ETX-4143 2.0Treatment with the ETX-4143 2.0 device |
| Control | Sham comparator | Device: ETX-4143 2.0Treatment with a sham ETX-4143 2.0 device |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| ETX-4143 2.0Treatment of the eye with the ETX-4143 2.0 device | Device | Control, Investigational |
Primary outcome
Reduction of eye pain
Time frame: Eight weeks
Patient reported level of eye pain
Adverse events
Time frame: Eight weeks
Adverse events related to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 42101550Galor 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.
- 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. This study is not recruiting at the moment.
Patrick R Casey, OD study chair
VP of Clinical Develpment
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETX-4143 2.0 in people with Eye Pain, run by EyeCool Therapeutics, Inc. at 4 sites 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of eye pain (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 NCT06479382, which also lists 1 linked publication.
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 22 Aug 2025.