Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:50 AM
Study NCT ID:
NCT03104894
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2017-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'patient will be assigned to the study/control group by randomization soft ware. The results will be documented and kept by the doctor who preforms the meibomian glands massage/ sham massage. All patients will receive study number. Follow up examination will be preformed by another doctor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-04-02', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Tear Break up Time TBUT.', 'timeFrame': '1 month', 'description': 'Tear break up time will be measured in seconds. The score is expected to be higher.'}, {'measure': 'Improvement in Ocular Surface Disease Index questionnaire score (OSDI)', 'timeFrame': '1 month', 'description': 'OSDI score will be calculated according a formula: (sum of scores) X 25 divided by the number of questions answered. The score is expected to be lower.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MGD-Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone.\n\nThe meibomian glands secrete meibum which is the oily component of the tear film layer. The meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .\n\nMeibomian gland dysfunction is a common condition that affects 39%-50% of the population. It is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are rosacea and dry eye syndrome .\n\nSign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and blur.\n\nSpectrometry analysis shows change it the fatty acids conformation such as increase in levels of branched-chain fatty acids and decrease in saturated fatty acids .\n\nSubsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion granular-toothpaste like.\n\nAlthough MGD is not often accompanied with inflammatory signs it is a common cause for evaporative dry eye.', 'detailedDescription': "In order to investigate the relation between meibomian gland massage outcomes and signs and symptoms of dry eye, randomized prospective study will be conducted. Patients, who arrive to Barzilai Medical Center out patients' clinic, are diagnosed with MGD 2-3 and signed informed consent form shall be included in the trial, then randomized to study group or control group.\n\nThe study group will receive meibomian glands massage and artificial drops PRN, whereas the control group will receive sham massage and artificial drops. Each visit at the clinic will include dry examinations and questionnaire.\n\nFollow up examination are due after one week, monthly visits up to 4 months, then after half year, 8 months and one year.\n\nStatistical methods: in order to evaluate to treatment effect T-Test analysis will be calculated, significant result is when P\\<0.05.\n\nData will be recorded into to electronic sheets. Subjects' confidentiality will be assured by masking any identifying details and a random number will be assigned prior results analysis stage"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Individuals (ageā„18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.\n\nExclusion Criteria:\n\n* pregnant women, subjects who received prior Meibomian gland massage.'}, 'identificationModule': {'nctId': 'NCT03104894', 'briefTitle': 'The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Barzilai Medical Center'}, 'officialTitle': 'The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye', 'orgStudyIdInfo': {'id': '0137-13-BRZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'The study group will receive meibomian glands massage and artificial drops PRN', 'interventionNames': ['Procedure: Meibomian Glands Massage', 'Device: Meibomian Massage device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'The control group will receive sham meibomian glands massage and artificial drops PRN.', 'interventionNames': ['Procedure: Sham Meibomian Glands Massage']}], 'interventions': [{'name': 'Meibomian Glands Massage', 'type': 'PROCEDURE', 'description': 'Meibomian gland expression', 'armGroupLabels': ['Study Group']}, {'name': 'Sham Meibomian Glands Massage', 'type': 'PROCEDURE', 'description': 'Touching the eyelids gently', 'armGroupLabels': ['Control Group']}, {'name': 'Meibomian Massage device', 'type': 'DEVICE', 'description': 'Meibomian glands expression with applicator', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78278', 'city': 'Ashkelon', 'state': 'Is', 'country': 'Israel', 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barzilai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}