Study of the ETX-4143 2.0 Device in Subjects With Eye Pain
NCT ID: NCT06479382
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2024-08-01
2024-11-29
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Investigational
Treatment with the ETX-4143 2.0 device
ETX-4143 2.0
Treatment of the eye with the ETX-4143 2.0 device
Control
Treatment with a sham ETX-4143 2.0 device
ETX-4143 2.0
Treatment of the eye with the ETX-4143 2.0 device
Interventions
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ETX-4143 2.0
Treatment of the eye with the ETX-4143 2.0 device
Eligibility Criteria
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Inclusion Criteria
* Willing to forgo participation in any other clinical stud for the duration of this study
* Demonstrate sufficient cognitive awareness to comply with the examination process
* Willing and able to comply with the schedule for follow-up visits
* Willing to participate in the study as evidenced by signing an informed consent document
Exclusion Criteria
* Any active ocular infection or active ocular inflammation at the time of the screening visit
* History of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, or topical anesthetic abuse
* Any history of significant eye surgery with the prior 90 days
* Planned eye surgery during the entire study
* Participation in any clinical study of an investigational product within 30 days prior to enrollment
* Any history of serious, poorly controlled systemic or ophthalmic condition that could compromise the subject's ability to comply with the protocol or compromise their safety
22 Years
90 Years
ALL
Yes
Sponsors
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EyeCool Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick R Casey, OD
Role: STUDY_CHAIR
VP of Clinical Develpment
Locations
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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
Countries
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Other Identifiers
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ETX4143-A002
Identifier Type: -
Identifier Source: org_study_id
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