Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542276
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Single Lipiflow Treatment to Reduce Pharmacologic Burden in DED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Vectored Thermal Pulsation Treatment in Patients Using Topical Immunomodulators in the Management of Dry Eye Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reduce
Brief Summary:
Purpose To evaluate the efficacy of vectored thermal pulsation treatment in subjects with a history of dry eye disease currently using a topical immunomodulator medication
Detailed Description:
Prospective non-randomized interventional study Subjects with bilateral use of a topical immunomodulator drop and a history of dry eye disease were recruited to participate All subjects underwent a vectored thermal pulsation treatment LipiFlow Patients were seen at baseline in a visit immediately prior to treatment and at months 1 and 3 following treatment Data collected included tear osmolarity tear break up time TBUT tear meniscus height TMH meibomian gland function and patient-reported symptoms using the ocular surface disease index OSDI questionnaire Following the 3-month visit patients were given the option to resume topical immunomodulator therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None