Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-31 @ 12:34 PM
Study NCT ID:
NCT03291704
Status:
UNKNOWN
Last Update Posted:
2018-03-19
First Post:
2017-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
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'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds', 'timeFrame': 'Before and after 4 weeks of daily treatment', 'description': 'Ocular surface analysis of tear film evaporation'}], 'secondaryOutcomes': [{'measure': 'Change in Ocular Surface Disease Index (OSDI) Score', 'timeFrame': 'Before and after 4 weeks of daily treatment', 'description': 'Standardized symptom questionnaire'}, {'measure': 'Meibum Expressibility', 'timeFrame': 'Before and after 4 weeks of daily treatment', 'description': 'Grade of Meibum oil expressibility from Meibomian Gland'}, {'measure': 'Sleep Quality', 'timeFrame': 'Before and after 4 weeks of daily treatment', 'description': 'Pittsburg Sleep Quality Index (PSQI)'}, {'measure': 'State Trait and Anxiety', 'timeFrame': 'Before and after 4 weeks of daily treatment', 'description': 'State-Trait Anxiety Index (STAI)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Thermal Therapy', 'Meibomian Gland Dysfunction'], 'conditions': ['Meibomian Gland Dysfunction', 'Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.\n\nThis will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.', 'detailedDescription': 'This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of MGD\n* Minimum age 18 years\n\nExclusion Criteria:\n\n* History of ocular disease, trauma, surgery (other than refractive), orbital cancer\n* 3 month history of ocular infection and/or ocular inflammation not associated with dry eye\n* 3 month history of any active physician administered or prescription dry eye treatment\n* Pregnant, potentially pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT03291704', 'briefTitle': 'Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'UMay Care Inc.'}, 'officialTitle': 'PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': 'Meibomian Gland Dysfunction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal Therapy', 'description': 'Heat application using at home thermal therapy device', 'interventionNames': ['Device: Thermal therapy device']}], 'interventions': [{'name': 'Thermal therapy device', 'type': 'DEVICE', 'otherNames': ['umayREST'], 'description': 'Thermal therapy of blocked Meibomian glands', 'armGroupLabels': ['Thermal Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sharmin Habib, OD', 'role': 'CONTACT', 'email': 'sharmin@umay.care', 'phone': '5875017422'}], 'overallOfficials': [{'name': 'Hermina Strungaru, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMay Care Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}