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

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.

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.

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