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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Treatment of the eye with the ETX-4143 2.0 device
Westmead Hospital
Westmead, New South Wales, Australia
Ophthamic Trials Australia
Brisbane, Queensland, Australia
Innovative Eye Care
Adelaide, South Australia, Australia
Sunshine Eye Surgeons
St Albans, Victoria, Australia
Reduction of eye pain
Patient reported level of eye pain
Time frame: Eight weeks
Adverse events
Adverse events related to treatment
Time frame: Eight weeks
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