Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06064071
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-09-26
Brief Title:
Clinical Study Evaluating Nordlys SWT IPL for Dry Eye Disease DED Due to MGD
Sponsor:
Candela Corporation
Organization:
Candela Corporation
Study Overview
Official Title:
Clinical Study Evaluating Nordlys SWT IPL for Dry Eye Disease DED Due to MGD
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Clinical Study Evaluating Nordlys System with Selective Waveband Technology SWT Intense Pulsed Light IPL Applicators for Dry Eye Disease DED due to Meibomian Gland Dysfunction MGD
Detailed Description:
Subjects will be randomized 11 to an experimental study group and a sham comparator control group
Subjects in the experimental group will receive four 4 IPL treatments and meibomian gland expression MGX at 2-week intervals IPL pulses will be administered on the skin of the malar region and below the lower eyelids Following IPL therapy subjects will undergo MGX of both eyelids in both eyes Subjects in the control group will receive the same treatment IPL followed by MGX except that the IPL administration will be performed with the device off sham treatment Follow-up visits will occur at 1 month and 3 months after the final treatment session At the follow-up the changes in the outcome measures will be evaluated and compared between the two groups
Subjects in the experimental group will receive four 4 IPL treatments and meibomian gland expression MGX at 2-week intervals IPL pulses will be administered on the skin of the malar region and below the lower eyelids Following IPL therapy subjects will undergo MGX of both eyelids in both eyes Subjects in the control group will receive the same treatment IPL followed by MGX except that the IPL administration will be performed with the device off sham treatment Follow-up visits will occur at 1 month and 3 months after the final treatment session At the follow-up the changes in the outcome measures will be evaluated and compared between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None