Status:
COMPLETED
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Virginia Lions Institute Foundation
Conditions:
Dry Eye Disease
Meibomian Gland Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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) wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06058559
Start Date
June 20 2023
End Date
October 26 2023
Last Update
March 15 2024
Active Locations (1)
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1
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037