Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-29 @ 4:08 AM
Study NCT ID:
NCT06058559
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant, Investigator)'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline of the SPEED questionnaire score at Day 90', 'timeFrame': '90 days', '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)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90', 'timeFrame': '90 days', '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)'}, {'measure': 'Change in number of MMP-positive eyes at Day 90', 'timeFrame': '90 days', 'description': 'InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.'}, {'measure': 'Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90', 'timeFrame': '90 days', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease', 'Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than18 at the time of informed consent\n* Clinical diagnosis of dry eye in both eyes\n* Fluorescein tear film break-up time (TBUT) less than 10s in both eyes\n* The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination\n* Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye\n* Patient Evaluation of Eye Dryness (SPEED) questionnaire score \\>6 to \\<14\n* Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions\n\nExclusion Criteria:\n\n* Any pre-existing ocular disease other than dry eye disease\n* Patients with inability to swallow soft gel capsules\n* Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.\n* Drastic change of food and/or food supplements within the last month.\n* Other food supplement with fatty acids\n* Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.\n* Ocular surgery within the last 6 months.\n* Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.\n* Occlusion therapy with lacrimal or punctum plugs within the last 3 months.\n* Alterations of the lacrimal drainage system\n* Eyelid abnormalities\n* Patients on oral tetracycline or corticosteroids\n* Active allergy or infection at the ocular surface'}, 'identificationModule': {'nctId': 'NCT06058559', 'briefTitle': 'Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease', 'orgStudyIdInfo': {'id': '101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sunflower Lecithin', 'description': 'Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules', 'interventionNames': ['Dietary Supplement: Sunflower lecithin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive Oil', 'description': 'Total 4000 mg olive oil per day taken in 4 softgel capsules', 'interventionNames': ['Dietary Supplement: Olive oil']}], 'interventions': [{'name': 'Sunflower lecithin', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['Sunflower Lecithin']}, {'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Extra virgin olive oil', 'armGroupLabels': ['Olive Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The GW Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'David Belyea, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The George Washington University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Virginia Lions Institute Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}