Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-31 @ 3:25 AM
Study NCT ID:
NCT05859295
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D022125', 'term': 'Lacerations'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Non-invasive tear break up time', 'timeFrame': '3 weeks', 'description': 'Videokeratoscope assessment of time to break up of the tear film'}, {'measure': 'Tear lipid layer thickness', 'timeFrame': '3 weeks', 'description': 'Interferometric assessment of the tear film lipid layer'}, {'measure': 'Tear meniscus height', 'timeFrame': '3 weeks', 'description': 'Videokeratoscope assessment of the tear meniscus'}], 'primaryOutcomes': [{'measure': 'Meibum protein composition', 'timeFrame': '3 weeks', 'description': 'Proteomic analysis of meibum collected before and after low level light therapy'}], 'secondaryOutcomes': [{'measure': 'Meibum lipid composition', 'timeFrame': '3 weeks', 'description': 'Lipidomic analysis of meibum collected before and after low level light therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Meibomian glands', 'meibomian gland dysfunction', 'tears'], 'conditions': ['Meibomian Gland Dysfunction', 'Dry Eye']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are:\n\n1. Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum\n2. Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum\n\nParticipants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.', 'detailedDescription': 'Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years or older at enrollment\n* Individuals with mild to moderate meibomian gland dysfunction based on clinical signs, e.g., meibum quality score of 1-3, meibography score of 1, 2, or 3 on the Pult Meiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an Ocular Surface Disease Index (OSDI) score of 13 to 32 points\n\nExclusion Criteria:\n\n* History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)\n* History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months\n* History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level light therapy (LLLT) within the last 12 months\n* Use of photosensitizing medications\n* Pregnant and/or lactating females\n* Pigmented lesions, tattoos, or skin cancer in the periocular region"}, 'identificationModule': {'nctId': 'NCT05859295', 'acronym': 'ELOM', 'briefTitle': 'Evaluation of Low-Level Light Therapy on Meibomian Glands Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Evaluation of Low-Level Light Therapy on Meibomian Glands Study', 'orgStudyIdInfo': {'id': 'STUDY00004024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Low-Level Light Therapy', 'description': 'All subjects will receive 3 15-minute treatments of low level light therapy', 'interventionNames': ['Device: Red Low-Level Light Therapy']}], 'interventions': [{'name': 'Red Low-Level Light Therapy', 'type': 'DEVICE', 'otherNames': ['Marco Equinox'], 'description': 'Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask', 'armGroupLabels': ['Low-Level Light Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Houston College of Optometry', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Eric R Ritchey, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Houston College of Optometry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Louisville', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eric R. Ritchey', 'investigatorAffiliation': 'University of Houston'}}}}