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

George Washington University (GW)

Status: Completed

Conditions: Meibomian Gland Dysfunction; Dry Eye Disease

Treatments: Dietary Supplement: Sunflower lecithin; Dietary Supplement: Olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06058559

101

Details and patient eligibility

About

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

Full 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).

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Sunflower Lecithin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sunflower lecithin

Olive Oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Olive oil