Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
Study of the ETX-4143 20 Device in Subjects With Eye Pain
Sponsor:
EyeCool Therapeutics Inc
Organization:
EyeCool Therapeutics Inc
Study Overview
Official Title:
A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 20 Device in Subjects With Eye Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 20 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 20 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 21 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 20 device
All subjects will be followed for 8 weeks Subjects will only have the worse eye treated if both eyes meet the inclusionexclusion criteria
A medical monitor will evaluate the safety of the study on a continual basis
It is anticipated that the learnings from the study will be used to design future study of the ETX-4143 20 device
All subjects will be followed for 8 weeks Subjects will only have the worse eye treated if both eyes meet the inclusionexclusion criteria
A medical monitor will evaluate the safety of the study on a continual basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None