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NCT Number: NCT06058559

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The GW Medical Faculty Associates

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

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Olive Oil

Dietary Supplement

Extra virgin olive oil

Primary outcomes

  1. Change from Baseline of the SPEED questionnaire score at Day 90

    Time frame: 90 days

    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)

Secondary outcomes

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

    Time frame: 90 days

    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)

  2. Change in number of MMP-positive eyes at Day 90

    Time frame: 90 days

    InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.

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

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Virginia Lions Institute Foundation

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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