Clinical trial NCT06058559: Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Official title: Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Meibomian Gland Dysfunction
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Virginia Lions Institute Foundation
First posted: 2023-09-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: Inclusion Criteria:

* Age greater than18 at the time of informed consent
* Clinical diagnosis of dry eye in both eyes
* Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
* The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
* Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
* Patient Evaluation of Eye Dryness (SPEED) questionnaire score \>6 to \<14
* Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions

Exclusion Criteria:

* Any pre-existing ocular disease other than dry eye disease
* Patients with inability to swallow soft gel capsules
* Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
* Drastic change of food and/or food supplements within the last month.
* Other food supplement with fatty acids
* Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.
* Ocular surgery within the last 6 months.
* Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.
* Occlusion therapy with lacrimal or punctum plugs within the last 3 months.
* Alterations of the lacrimal drainage system
* Eyelid abnormalities
* Patients on oral tetracycline or corticosteroids
* Active allergy or infection at the ocular surface

Primary outcomes:
measure: Change from Baseline of the SPEED questionnaire score at Day 90
timeFrame: 90 days
Secondary outcomes:
measure: Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90
timeFrame: 90 days
measure: Change in number of MMP-positive eyes at Day 90
timeFrame: 90 days
measure: Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90
timeFrame: 90 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: David Belyea, MD
role: STUDY_CHAIR
References: