Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741398
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-02-14
Brief Title:
Evaluation of Optical System in the Treatment of - Dry Eye Disease
Sponsor:
Demaod Ltd
Organization:
Demaod Ltd
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease DED Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
Single-center Prospective Open Label with Before-After Study Design to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease
Detailed Description:
Single-center Prospective Open Label with Before-After Study Design Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects
All subjects will undergo 3 treatments two weeks apart 2 weeks -3 days from the previous treatment
Follow-up visits after the last treatment visit 4 weeks 7 days 12 weeks 7 days
All subjects will undergo 3 treatments two weeks apart 2 weeks -3 days from the previous treatment
Follow-up visits after the last treatment visit 4 weeks 7 days 12 weeks 7 days
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