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

NCT06058559 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90

  90 days

• Change in number of MMP-positive eyes at Day 90

  90 days

• Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90

  90 days

Study Arms (2)

Sunflower Lecithin

EXPERIMENTAL

Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules

Dietary Supplement: Sunflower lecithin

Olive Oil

PLACEBO COMPARATOR

Total 4000 mg olive oil per day taken in 4 softgel capsules

Dietary Supplement: Olive oil

Interventions

Sunflower lecithin DIETARY_SUPPLEMENT

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

Sunflower Lecithin

Olive oil DIETARY_SUPPLEMENT

Extra virgin olive oil

Olive Oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead
• Virginia Lions Institute Foundation: collaborator

Study Sites (1)

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Belyea, MD

  The George Washington University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: June 20, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)