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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058559
• Other study ID #: 101
• Status: Completed
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: March 2024
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

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
• Olive oil
Extra virgin olive oil

Locations

Country	Name	City	State
United States	The GW Medical Faculty Associates	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Virginia Lions Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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