Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease

This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.

Study Overview

• Status: Completed
• Conditions: Meibomian Gland Dysfunction; Dry Eye Disease
• Intervention / Treatment: Dietary supplement: Sunflower lecithin; Dietary supplement: Olive oil

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith Wroblowski, MD; Phone Number: 202-741-2800; Email: kwroblewski@mfa.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The GW Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sunflower Lecithin; Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules	Dietary supplement: Sunflower lecithin; Lecithins are a group of essential phospholipids that are involved in a number of biological functions such as lipid-cholesterol transport, transmembrane signaling, and neurological function
Placebo Comparator: Olive Oil; Total 4000 mg olive oil per day taken in 4 softgel capsules	Dietary supplement: Olive oil; Extra virgin olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of the SPEED questionnaire score at Day 90	To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic). Change = (Day 90 score - Baseline score)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90	Fluorescein Tear Break-Up Time (TBUT) is a measurement in seconds of tear film stability. The shorter the TBUT, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 90 value - Baseline value)	90 days
Change in number of MMP-positive eyes at Day 90	InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.	90 days
Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90	Meibomian glands on the eyelids assessed by the examiner using a Meibomian Gland Evaluator (MGE) and a slit lamp microscope. An MGE instrument applies a standardized force simulating the pressure of a deliberate blink allowing eye care professionals to observe meibomian gland functionality through a slit lamp. 5 glands in 1 zone (nasal) evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 15 for each eye. Scoring as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.	90 days

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Virginia Lions Institute Foundation
• Investigators: Study Chair: David Belyea, MD, The George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: 101 (Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No