Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT06058559
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Sponsor:
George Washington University
Organization:
Study Overview
Official Title:
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.
Detailed Description:
Enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. Patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). Patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (SPEED survey), Tear Breakup Time Measurement, Meibomian Gland Score, and a rapid in-office assessment of years (InflammaDry).
Study Oversight
Has Oversight DMC:
False
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?: