Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2026-03-09 @ 12:20 AM
Study NCT ID:
NCT01683318
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2012-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Meibomian Gland Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2013-11-11', 'studyFirstSubmitDate': '2012-09-04', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ocular discomfort', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Tear Break Up Time (TBUT)', 'timeFrame': '3 months'}, {'measure': 'Number of blocked meibomian glands', 'timeFrame': '3 months'}, {'measure': 'Corneal fluorescein staining score', 'timeFrame': '3 months'}, {'measure': 'To measure the production of tears', 'timeFrame': '3 months', 'description': "Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured."}, {'measure': 'Tear evaporimetry', 'timeFrame': '3 months'}, {'measure': 'Lipid layer thickness', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction (MGD)']}, 'referencesModule': {'references': [{'pmid': '27096755', 'type': 'DERIVED', 'citation': 'Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.'}]}, 'descriptionModule': {'briefSummary': 'The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.\n\nPatients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.\n\nThe investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.\n2. At least one out of 8 questions on dry eye symptoms is answered with often or all the time.\n3. Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.\n\nExclusion Criteria:\n\n1. Known history of thyroid disorders (diagnosed by physician).\n2. No ocular surgery within the previous 6 months and LASIK within the previous 1 year.\n3. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.\n4. Active ocular infection or pterygium.\n5. Anticipated necessity to wear contact lens in the duration of the study.\n6. Living in the same household as another participant of the study.\n7. Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.'}, 'identificationModule': {'nctId': 'NCT01683318', 'briefTitle': 'Treatment of Meibomian Gland Dysfunction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Singapore National Eye Centre'}, 'officialTitle': 'Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': 'R913/22/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).', 'interventionNames': ['Procedure: Thermal Pulsation therapy']}], 'interventions': [{'name': 'Thermal Pulsation therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '168751', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore National Eye Centre', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore National Eye Centre', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician-Scientist', 'investigatorFullName': 'Louis Tong', 'investigatorAffiliation': 'Singapore National Eye Centre'}}}}