Ocular HypertensionNCT06709300
An Observational Study to Evaluate the ETX-4143 Device in Subjects With Ocular Hypertension
An observational study of Ocular Hypertension, run by EyeCool Therapeutics, Inc. at 1 site in Australia.
Trial summary
This study aims to assess the effectiveness of the EyeCool ETX-4143 device in reducing intraocular pressure (IOP) in eyes with ocular hypertension, regardless of a formal diagnosis of primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ocular Hypertension
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2026to Jul 2026
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals that have been diagnosed with hypertension and are seen in the general patient population of an ophthalmic primary care clinic
Who may be able to join
- Adult patients age ≥40 years of age of any gender
- Has been diagnosed with elevated IOP (all readings should be taken within the same 4hr daytime window) with a reading of > 21mm Hg in the eye to be studied.
- Is either not being treated for elevated IOP or is using ocular hypotensive medication to control IOP.
- Have an open angle of the anterior chamber with evidence of trabecular meshwork visible on gonioscopy
- Willing to forgo participation in any other clinical study for the duration of this study
- Demonstrate sufficient cognitive awareness to comply with the examination process
- Willing and able to comply with schedule for follow-up visits
- Willing to participate in the study as evidenced by signing of 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
- Known allergy or hypersensitivity to copper, aluminum, or silicone
- Have previously undergone penetrating intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, trabeculectomy, or tube bypass) in any quadrant of the study eye
- Have undergone laser trabeculoplasty (ALT, MLT, or SLT, or cilio-ablative therapy such as cyclophotocoagulation (CPC)) within 90 days prior to starting the study
- Any active ocular infection (bacterial, viral, or fungal), or active ocular inflammation at the time of the Screening Visit (note- potential subjects can return for rescreening at a later date after the infection or inflammation has resolved.)
- History of corneal transplant (penetrating keratoplasy or endothelial keratoplasty), significant corneal endothelial disease, keratoconus, corneal thinning, or other corneal ectasias
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- A history of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, topical anesthetic abuse, or any other cause
- Any history of significant conjunctival surgery within the prior 90 days such as pterygium removal, or any presence of any subconjunctival implant (scleral buckle surgery).
- Planned eye surgery or other ophthalmic procedures within 90 days following treatment.
- 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 or circumstances, including those identified in the screening visit which, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the clinical trial results.
- Neuropsychiatric disorder (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness that has required hospitalization within the last 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Feasibility Study to Evaluate the Safety and Effectiveness of the ETX-4143 Device in Subjects With Ocular Hypertension
This study aims to assess the effectiveness of the EyeCool ETX-4143 device in reducing intraocular pressure (IOP) in eyes with ocular hypertension, regardless of a formal diagnosis of primary open-angle glaucoma. The primary objective is to determine whether the EyeCool device can effectively lower IOP in individuals with elevated eye pressure. Participants currently using intraocular pressure-lowering medications but still experiencing elevated IOP may also be eligible to participate.
Read the detailed description
This is a prospective feasibility study designed to evaluate the safety and effectiveness of the EyeCool ETX-4143 device in lowering intraocular pressure (IOP) in eyes with ocular hypertension.
Elevated IOP can negatively affect the optic nerve, often resulting from various clinical conditions. The progression of IOP elevation is typically gradual and painless, which may lead to it going unnoticed by the patient. If left untreated, significantly elevated IOP can cause permanent visual field reduction and vision loss.
Ocular hypertension may occur with or without a formal diagnosis of primary open-angle glaucoma. Additionally, individuals with ocular hypertension may or may not be on ocular hypotensive medications to manage their condition.
This exploratory study aims to determine whether treatment with the EyeCool device results in a safe and effective reduction in IOP. Up to 30 eyes with ocular hypertension will be enrolled and followed for 12 weeks after treatment.
If both eyes meet the inclusion and exclusion criteria, only the eye with the higher IOP will be treated. Participants will not be required to discontinue or modify their use of IOP-lowering medications during the study.
Study findings are expected to inform the design of future clinical trials assessing the ETX-4143 device for the treatment of elevated IOP.
- Conditions
- Ocular Hypertension
- Keywords
- Ocular Hypertension, intraocular pressure, Elevated IOP, Eye Diseases, Glaucoma, Raised intraocular pressure
- Medical subject headings
- Ocular Hypertension, Eye Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Open-label treatment group with the EyeCool ETX-4143 device in eyes with ocular hypertension that meet the inclusion/exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual percent reduction in IOP
Individual percent reduction in intraocular pressure at each post-treatment exam compared to baseline while maintaining the same concomitant ocular hypotensive medication regimen, if any.
Measured: From treatment to the end of twelve weeks
Mean reduction in intraocular pressure
Mean reduction in IOP at each post-treatment exam compared to baseline while maintaining the same concomitant ocular hypotensive medication regime, if any.
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 posted29 Nov 2024
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Executive decision by the company not to execute the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeCool Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EyeCool Therapeutics, Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Patrick R Casey, OD, Study chair, EyeCool Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709300
- Sponsor's protocol ID
- ETX4143-A003
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study to Evaluate the Safety and Effectiveness of the ETX-4143 Device in Subjects With Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06709300
- Acronym / sponsor ID
- ETX4143-A003
- Conditions
- Ocular Hypertension
- Keywords
- Ocular Hypertension, intraocular pressure, Elevated IOP, Eye Diseases, Glaucoma, Raised intraocular pressure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Executive decision by the company not to execute the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EyeCool Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- EyeCool Therapeutics, Pty Ltd
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Nov 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.
This study aims to assess the effectiveness of the EyeCool ETX-4143 device in reducing intraocular pressure (IOP) in eyes with ocular hypertension, regardless of a formal diagnosis of primary open-angle glaucoma. The primary objective is to determine whether the EyeCool device can effectively lower IOP in individuals with elevated eye pressure. Participants currently using intraocular pressure-lowering medications but still experiencing elevated IOP may also be eligible to participate.
Detailed description
This is a prospective feasibility study designed to evaluate the safety and effectiveness of the EyeCool ETX-4143 device in lowering intraocular pressure (IOP) in eyes with ocular hypertension.
Elevated IOP can negatively affect the optic nerve, often resulting from various clinical conditions. The progression of IOP elevation is typically gradual and painless, which may lead to it going unnoticed by the patient. If left untreated, significantly elevated IOP can cause permanent visual field reduction and vision loss.
Ocular hypertension may occur with or without a formal diagnosis of primary open-angle glaucoma. Additionally, individuals with ocular hypertension may or may not be on ocular hypotensive medications to manage their condition.
This exploratory study aims to determine whether treatment with the EyeCool device results in a safe and effective reduction in IOP. Up to 30 eyes with ocular hypertension will be enrolled and followed for 12 weeks after treatment.
If both eyes meet the inclusion and exclusion criteria, only the eye with the higher IOP will be treated. Participants will not be required to discontinue or modify their use of IOP-lowering medications during the study.
Study findings are expected to inform the design of future clinical trials assessing the ETX-4143 device for the treatment of elevated IOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –Open-label treatment group with the EyeCool ETX-4143 device in eyes with ocular hypertension that meet the inclusion/exclusion criteria |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals that have been diagnosed with hypertension and are seen in the general patient population of an ophthalmic primary care clinic
Key inclusion criteria (8 listed)
- Adult patients age ≥40 years of age of any gender
- Has been diagnosed with elevated IOP (all readings should be taken within the same 4hr daytime window) with a reading of > 21mm Hg in the eye to be studied.
- Is either not being treated for elevated IOP or is using ocular hypotensive medication to control IOP.
- Have an open angle of the anterior chamber with evidence of trabecular meshwork visible on gonioscopy
- Willing to forgo participation in any other clinical study for the duration of this study
Key exclusion criteria (12 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
- Known allergy or hypersensitivity to copper, aluminum, or silicone
- Have previously undergone penetrating intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, trabeculectomy, or tube bypass) in any quadrant of the study eye
- Have undergone laser trabeculoplasty (ALT, MLT, or SLT, or cilio-ablative therapy such as cyclophotocoagulation (CPC)) within 90 days prior to starting the study
- Any active ocular infection (bacterial, viral, or fungal), or active ocular inflammation at the time of the Screening Visit (note- potential subjects can return for rescreening at a later date after the infection or inflammation has resolved.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individual percent reduction in IOP
Time frame: From treatment to the end of twelve weeks
Individual percent reduction in intraocular pressure at each post-treatment exam compared to baseline while maintaining the same concomitant ocular hypotensive medication regimen, if any.
Mean reduction in intraocular pressure
Time frame: From treatment to the end of twelve weeks
Mean reduction in IOP at each post-treatment exam compared to baseline while maintaining the same concomitant ocular hypotensive medication regime, if any.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- 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
EyeCool Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Hypertension, 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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Individual percent reduction in IOP (time frame: From treatment to the end of twelve 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?
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 11 Jul 2025.