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

NCT06709300 | Withdrawn

• 1 other identifier: ETX4143-A003
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Hypertension

Keywords

Ocular Hypertension; intraocular pressure; Elevated IOP; Eye Diseases; Glaucoma; Raised intraocular pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From treatment to the end of twelve weeks

Study Arms (1)

Study Cohort

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• EyeCool Therapeutics, Inc.: lead
• EyeCool Therapeutics, Pty Ltd: collaborator

Study Sites (1)

Ophthalmic Trials Australia

Brisbane, Queensland, 4005, Australia

Location

MeSH Terms

Conditions

Ocular Hypertension; Eye Diseases; Glaucoma

Study Officials

• Patrick R Casey, OD

  EyeCool Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 29, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)