Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT03840668
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2018-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Living Through Personalized Monitoring of Eyelid Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance of USB eyemask questionnaire', 'timeFrame': '2 months +/-14 days', 'description': 'Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['USB eyemask'], 'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': "Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period.", 'detailedDescription': "Dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness.\n\nPortable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. Such eyemasks can be plugged into a copyrighted device developed in collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. The cloud database only allows access to administrator and will be password protected. You or your physician can monitor the frequency of eyelid warming over a long period. To further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must be 21 years or older.\n2. Subject must have severe MGD\n3. Subject must be willing to answer the questions in the questionnaire\n4. Subject must be willing to use the USB-powered eyemask as instructed\n5. Subject must have the ability to provide informed consent\n6. Subject must be willing to come back for follow-up visit\n\nExclusion Criteria:\n\n1. Any other specified reason as determined by the clinical investigator.\n2. Is pregnant, lactating or planning a pregnancy.'}, 'identificationModule': {'nctId': 'NCT03840668', 'briefTitle': 'Healthy Living Through Personalized Monitoring of Eyelid Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Singapore National Eye Centre'}, 'officialTitle': 'Healthy Living Through Personalized Monitoring of Eyelid Care', 'orgStudyIdInfo': {'id': 'R1507/6/2018'}, 'secondaryIdInfos': [{'id': '2018/2102', 'type': 'REGISTRY', 'domain': 'SingHealth CIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry eye', 'description': 'Participants who will be using the USB-powered eye mask.', 'interventionNames': ['Device: USB Eye Mask']}], 'interventions': [{'name': 'USB Eye Mask', 'type': 'DEVICE', 'description': 'To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 2 months.', 'armGroupLabels': ['Dry eye']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169856', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore Eye Research Institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Louis Tong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore Eye Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore National Eye Centre', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ngee Ann Polytechnic Singapore', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician-Scientist, Senior Consultant', 'investigatorFullName': 'Louis Tong', 'investigatorAffiliation': 'Singapore National Eye Centre'}}}}