NCT06479382

Study of the ETX-4143 2.0 Device in Subjects With Eye Pain

A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects With Eye Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: EyeCool Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years – 90 Years
• Healthy volunteers: Accepted

Summary

A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects with eye pain

Detailed description

A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects who suffer from eye pain an do not get relieve from current medications or clinical treatments. Thirty eyes will be enrolled and randomized 2:1 to the investigational treatment or a sham treatment. Improvement in self-reported ocular pain and clinical safety measures will be evaluated. It is anticipated that the learnings from the study will be used to design future study of the ETX-4143 2.0 device. All subjects will be followed for 8 weeks. Subjects will only have the worse eye treated if both eyes meet the inclusion/exclusion criteria. A medical monitor will evaluate the safety of the study on a continual basis.

Conditions

• Eye Pain

Interventions

Type	Name	Description
DEVICE	ETX-4143 2.0	Treatment of the eye with the ETX-4143 2.0 device

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2024-06-28
• Last updated: 2025-08-22

Locations

4 sites across 1 country: Australia