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

NCT ID: NCT06058559

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2023-10-26

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).

Conditions

Dry Eye Disease; Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Sunflower Lecithin

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

Group Type: EXPERIMENTAL

Sunflower lecithin

Intervention Type: 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

Olive Oil

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

Group Type: PLACEBO_COMPARATOR

Olive oil

Intervention Type: DIETARY_SUPPLEMENT

Extra virgin olive oil

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Olive oil

Extra virgin olive oil

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Lions Institute Foundation

UNKNOWN

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Belyea, MD

Role: STUDY_CHAIR

The George Washington University

Locations

The GW Medical Faculty Associates

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

Countries

United States

Other Identifiers

101

Identifier Type: -

Identifier Source: org_study_id