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| Name | Class |
|---|---|
| Virginia Lions Institute Foundation | UNKNOWN |
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This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunflower Lecithin | Experimental | Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules |
|
| Olive Oil | Placebo Comparator | Total 4000 mg olive oil per day taken in 4 softgel capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Belyea, MD | The George Washington University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Double (Participant, Investigator)
| Olive oil | Dietary Supplement | Extra virgin olive oil |
|
| Change in number of MMP-positive eyes at Day 90 |
InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears. |
| 90 days |
| 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. | 90 days |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |