A Prospective, Feasibility, Single-Center Clinical Study to Evaluate the Effect of the ETX-4143 Topical Ophthalmic Cooling Device on Ocular Surface Structures and Cell Population in Patients With Chronic Ocular Surface Pain

What this Trial Is About

Researchers are investigating the effects of an investigational cold treatment device called ETX-4143 on the eye's surface anatomy and inflammatory response in people with chronic ocular surface pain (COSP). This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eye's conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.

A Clinical Study to Determine What Effect the EyeCool Treatment Has on the Eye's Surface Anatomy and Inflammation Response After Being Treated for Having Chronic Ocular Surface Pain (COSP)