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

Launched by EYECOOL THERAPEUTICS, INC. · Nov 26, 2024

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ClinConnect Summary

This clinical trial is studying a device called the EyeCool ETX-4143, which is designed to help lower eye pressure in people with ocular hypertension. Ocular hypertension means that the pressure inside the eye is higher than normal, which can lead to vision problems over time. The goal of the study is to see if this device can effectively reduce that pressure, even in people who are already using medication for it. If you're over 40 years old and have been diagnosed with high eye pressure (greater than 21 mm Hg), you might be eligible to participate, whether or not you're currently on medication.

If you decide to join the study, you'll go through some eye examinations and follow-up visits to monitor your eye pressure and overall health. It's important to know that certain conditions or recent eye surgeries may prevent you from participating, as well as if you're pregnant or breastfeeding. This study will not be recruiting participants just yet, but if you meet the criteria and are interested, you can keep an eye out for when it begins. Your involvement could help researchers better understand how to manage elevated eye pressure and improve care for others in the future.

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Eligibility criteria

• 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:
• • 9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
• • 10. Known allergy or hypersensitivity to copper, aluminum, or silicone
• • 11. Have previously undergone penetrating intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, trabeculectomy, or tube bypass) in any quadrant of the study eye
• • 12. Have undergone laser trabeculoplasty (ALT, MLT, or SLT, or cilio-ablative therapy such as cyclophotocoagulation (CPC)) within 90 days prior to starting the study
• • 13. 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.)
• • 14. History of corneal transplant (penetrating keratoplasy or endothelial keratoplasty), significant corneal endothelial disease, keratoconus, corneal thinning, or other corneal ectasias
• • 15. 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
• • 16. 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).
• • 17. Planned eye surgery or other ophthalmic procedures within 90 days following treatment.
• • 18. Participation in any clinical study of an investigational product within 30 days prior to enrollment
• • 19. 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.
• • 20. Neuropsychiatric disorder (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness that has required hospitalization within the last 6 months prior to screening