Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT06242860
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Human Factors and Usability Evaluation', 'timeFrame': 'one week, four weeks', 'description': 'Patients will participate in an Acceptance VAS Questionnaire'}], 'primaryOutcomes': [{'measure': 'Procedure-related adverse events', 'timeFrame': 'one week, four weeks', 'description': 'Incidence of procedure-related adverse events will be assessed'}, {'measure': 'Device-related adverse events', 'timeFrame': 'one week, four weeks', 'description': 'Incidence of device-related adverse events will be assessed'}], 'secondaryOutcomes': [{'measure': 'SPEED II Questionnaire for Dry Eye', 'timeFrame': 'one week, four weeks', 'description': 'Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline'}, {'measure': 'Slip Lamp Evaluation', 'timeFrame': 'one week, four weeks', 'description': 'Change of appearance of cornea under slit lamp evaluation compared to baseline'}, {'measure': 'Meibomian Gland Imaging', 'timeFrame': 'one week, four weeks', 'description': 'Change in meibomian gland under imaging compared to baseline'}, {'measure': 'Lipid Layer Thickness', 'timeFrame': 'one week, four weeks', 'description': 'Change in thickness of lipid layer compared to baseline'}, {'measure': 'Tear Break Up Time', 'timeFrame': 'one week, four weeks', 'description': 'Change in tear break up time compared to baseline'}, {'measure': 'Corneal Fluorescein Staining', 'timeFrame': 'one week, four weeks', 'description': 'Change in appearance of fluorescein staining compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['dry eye disease', 'meibomian gland dysfunction', 'evaporative dry eye disease', 'eye lipid mobilizer'], 'conditions': ['Evaporative Dry Eye Disease', 'Meibomian Gland Dysfunction']}, 'referencesModule': {'references': [{'pmid': '25136628', 'type': 'RESULT', 'citation': 'Semeraro F, Forbice E, Braga O, Bova A, Di Salvatore A, Azzolini C. Evaluation of the efficacy of 50% autologous serum eye drops in different ocular surface pathologies. Biomed Res Int. 2014;2014:826970. doi: 10.1155/2014/826970. Epub 2014 Jul 22.'}, {'pmid': '25030896', 'type': 'RESULT', 'citation': 'Finis D, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. [Comparison of the OSDI and SPEED questionnaires for the evaluation of dry eye disease in clinical routine]. Ophthalmologe. 2014 Nov;111(11):1050-6. doi: 10.1007/s00347-014-3042-z. German.'}, {'pmid': '19668387', 'type': 'RESULT', 'citation': 'Savini G, Prabhawasat P, Kojima T, Grueterich M, Espana E, Goto E. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008 Mar;2(1):31-55. doi: 10.2147/opth.s1496.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.', 'detailedDescription': 'The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.\n\nThe secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 21 years old\n* Confirmed evaporative dry eye disease\n\nExclusion Criteria:\n\n* Ocular surgery, trauma, herpes infections\n* Unwillingness to comply with study protocol\n* Pregnant or nursing women\n* Any subject that cannot wear an eye mask\n* Participation in another ophthalmic clinical trial within past 30 days'}, 'identificationModule': {'nctId': 'NCT06242860', 'acronym': 'ELM', 'briefTitle': 'Clinical Study Using Eye Lipid Mobilizer (ELM) With Heat and Vibration To Treat Evaporative Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyedetec Medical, Inc.'}, 'officialTitle': 'A Prospective, Clinical Trial Eye Lipid Mobilizer (ELM) Using Heat and Vibration for the Treatment of Meibomian Gland Dysfunction (MGD)', 'orgStudyIdInfo': {'id': 'PTL 1011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single ELM Treatment', 'description': 'To undergo the ELM procedure, the subject will sit comfortably in an exam chair.\n\nThe Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed.', 'interventionNames': ['Device: ELM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daily ELM Treatment', 'description': 'To undergo the ELM procedure, the subject will sit comfortably in an exam chair.\n\nThe Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. Subject will take personalized ELM home and use it as directed on a daily basis', 'interventionNames': ['Device: ELM']}], 'interventions': [{'name': 'ELM', 'type': 'DEVICE', 'description': 'Treatment of dry eye with ELM device', 'armGroupLabels': ['Daily ELM Treatment', 'Single ELM Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95662', 'city': 'Citrus Heights', 'state': 'California', 'country': 'United States', 'facility': 'EYEcenter Optometric', 'geoPoint': {'lat': 38.70712, 'lon': -121.28106}}], 'overallOfficials': [{'name': 'CEO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eyedetec'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will not be publishing in ICMJE journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyedetec Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}