NCT06709300

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: EyeCool Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2024-11-29
• Last updated: 2025-07-11

Locations

1 site across 1 country: Australia