Back to resultsEffect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Primary Purpose
Dry Eye Disease, Meibomian Gland Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunflower lecithin
Olive oil
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Disease
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
Sites / Locations
- The GW Medical Faculty AssociatesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sunflower Lecithin
Olive Oil
Arm Description
Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules
Total 4000 mg olive oil per day taken in 4 softgel capsules
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90
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)
Change in number of MMP-positive eyes at Day 90
InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.
Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90
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.
Full Information
NCT ID
NCT06058559
First Posted
September 22, 2023
Last Updated
October 5, 2023
Sponsor
George Washington University
Collaborators
Virginia Lions Institute Foundation
1. Study Identification
Unique Protocol Identification Number
NCT06058559
Brief Title
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Official Title
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University
Collaborators
Virginia Lions Institute Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sunflower Lecithin
Arm Type
Experimental
Arm Description
Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules
Arm Title
Olive Oil
Arm Type
Placebo Comparator
Arm Description
Total 4000 mg olive oil per day taken in 4 softgel capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower lecithin
Intervention Description
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
Intervention Name(s)
Olive oil
Intervention Description
Extra virgin olive oil
Primary Outcome Measure Information:
Title
Change from Baseline of the SPEED questionnaire score at Day 90
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90
Description
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)
Time Frame
90 days
Title
Change in number of MMP-positive eyes at Day 90
Description
InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.
Time Frame
90 days
Title
Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Wroblowski, MD
Phone
202-741-2800
Email
kwroblewski@mfa.gwu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Belyea, MD
Organizational Affiliation
The George Washington University
Official's Role
Study Chair
Facility Information:
Facility Name
The GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith Wroblewski, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
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