Clinical trial NCT06479382: Study of the ETX-4143 2.0 Device in Subjects with Eye Pain
Official title: A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects with Eye Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Pain
Lead sponsor: EyeCool Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 31
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Documented history of eye pain with no relief from currently available medications or treatments
* 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:

* Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
* 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

Primary outcomes:
measure: Reduction of eye pain
timeFrame: Eight weeks
measure: Adverse events
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Ophthamic Trials Australia
state: Queensland
Study officials:
affiliation: VP of Clinical Develpment
name: Patrick R Casey, OD
role: STUDY_CHAIR
References: