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

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ClinicalTrials.gov Identifier: NCT06058559
Recruitment Status : Completed
First Posted : September 28, 2023
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
Virginia Lions Institute Foundation
Information provided by (Responsible Party):
George Washington University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Meibomian Gland Dysfunction Dietary Supplement: Sunflower lecithin Dietary Supplement: Olive oil Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Actual Study Start Date : June 20, 2023
Actual Primary Completion Date : October 26, 2023
Actual Study Completion Date : October 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sunflower Lecithin
Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules
 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
Placebo Comparator: Olive Oil
Total 4000 mg olive oil per day taken in 4 softgel capsules
 Dietary Supplement: Olive oil
Extra virgin olive oil


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06058559


Locations
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United States, District of Columbia
The GW Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Virginia Lions Institute Foundation
Investigators
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Study Chair: David Belyea, MD The George Washington University
More Information
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Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT06058559    
Other Study ID Numbers: 101
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Eyelid Diseases