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WithdrawnNCT06709300Updated Jul 11, 2025

An Observational Study to Evaluate the ETX-4143 Device in Subjects With Ocular Hypertension

An observational study in Ocular Hypertension, sponsored by EyeCool Therapeutics, Inc.. Withdrawn at 1 site in Australia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by EyeCool Therapeutics, Inc. · Observational

Why this study was withdrawn
Executive decision by the company not to execute the study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
40 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Ocular Hypertension

Keywords

  • Ocular Hypertension
  • intraocular pressure
  • Elevated IOP
  • Eye Diseases
  • Glaucoma
  • Raised intraocular pressure
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In context

Ocular Hypertension

649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.

Browse Ocular Hypertension studies →

Lead sponsor

EyeCool Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals that have been diagnosed with hypertension and are seen in the general patient population of an ophthalmic primary care clinic

Inclusion criteria

  1. Adult patients age ≥40 years of age of any gender
  2. 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.
  3. Is either not being treated for elevated IOP or is using ocular hypotensive medication to control IOP.
  4. Have an open angle of the anterior chamber with evidence of trabecular meshwork visible on gonioscopy
  5. Willing to forgo participation in any other clinical study for the duration of this study
  6. Demonstrate sufficient cognitive awareness to comply with the examination process
  7. Willing and able to comply with schedule for follow-up visits
  8. Willing to participate in the study as evidenced by signing of an informed consent document

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
  2. Known allergy or hypersensitivity to copper, aluminum, or silicone
  3. Have previously undergone penetrating intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, trabeculectomy, or tube bypass) in any quadrant of the study eye
  4. Have undergone laser trabeculoplasty (ALT, MLT, or SLT, or cilio-ablative therapy such as cyclophotocoagulation (CPC)) within 90 days prior to starting the study
  5. 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.)
  6. History of corneal transplant (penetrating keratoplasy or endothelial keratoplasty), significant corneal endothelial disease, keratoconus, corneal thinning, or other corneal ectasias
  7. 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
  8. 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).
  9. Planned eye surgery or other ophthalmic procedures within 90 days following treatment.
  10. Participation in any clinical study of an investigational product within 30 days prior to enrollment
  11. 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.
  12. Neuropsychiatric disorder (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness that has required hospitalization within the last 6 months prior to screening
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Study Cohort

    Open-label treatment group with the EyeCool ETX-4143 device in eyes with ocular hypertension that meet the inclusion/exclusion criteria

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From treatment to the end of twelve weeks

  2. 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.

    Time frame: From treatment to the end of twelve weeks

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Study locations

1 site
  • Ophthalmic Trials Australia
    Brisbane, Queensland 4005, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06709300
Lead sponsor
EyeCool Therapeutics, Inc.
Collaborators
EyeCool Therapeutics, Pty Ltd
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Jan 2026 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jul 11, 2025

Study contacts

Patrick R Casey, OD
study chair · EyeCool Therapeutics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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