Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT02256969
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraductal Meibomian Gland Probing Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014834', 'term': 'sulfanizolone'}, {'id': 'D013409', 'term': 'Sulfacetamide'}, {'id': 'C009935', 'term': 'prednisolone acetate'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ophthalmologyclinicalresearch@meei.harvard.edu', 'phone': '617-573-6060', 'title': 'Assistant Professor of Ophthalmology', 'phoneExt': '6060', 'organization': 'Massachusetts Eye and Ear Infirmary'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign Body Sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Surface Disease Index (OSDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'OG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '28.2', 'groupId': 'OG001'}, {'value': '37.3', 'spread': '21.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 week Time Point', 'description': 'A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Symptom Assessment in Dry Eye (SANDE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'OG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '47.6', 'spread': '25.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 week Time Point', 'description': 'A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Corneal Fluorescein Staining (CFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'OG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 week Time Point', 'description': 'Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tear Break Up Time (TBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'OG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 week Time Point', 'description': 'TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'FG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'FG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Screenfailed or withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Meibomian Gland Probing Plus Lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.\n\nLubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'BG001', 'title': 'Sham Meibomian Gland Probing Plus Lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."}, {'id': 'BG002', 'title': 'Meibomian Gland Probing Plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '17.4', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '15.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ocular Surface Disease Index (OSDI)', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '23.8', 'groupId': 'BG000'}, {'value': '49.1', 'spread': '27.1', 'groupId': 'BG001'}, {'value': '49.1', 'spread': '19.9', 'groupId': 'BG002'}, {'value': '47.9', 'spread': '23.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Symptom Assessment in Dry Eye (SANDE)', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '22.5', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '14.1', 'groupId': 'BG002'}, {'value': '67.5', 'spread': '17.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal Fluorescein Staining (CFS)', 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '0.9', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '1.6', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Corneal Fluorescein Staining (CFS) scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tear Film Break-Up Time (TBUT)', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '3.0', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2014-08-13', 'resultsFirstSubmitDate': '2017-04-14', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-14', 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index (OSDI)', 'timeFrame': '4 week Time Point', 'description': 'A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.'}, {'measure': 'Symptom Assessment in Dry Eye (SANDE)', 'timeFrame': '4 week Time Point', 'description': 'A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.'}, {'measure': 'Corneal Fluorescein Staining (CFS)', 'timeFrame': '4 week Time Point', 'description': 'Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.'}, {'measure': 'Tear Break Up Time (TBUT)', 'timeFrame': '4 week Time Point', 'description': 'TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction']}, 'referencesModule': {'references': [{'pmid': '32882429', 'type': 'DERIVED', 'citation': 'Kheirkhah A, Kobashi H, Girgis J, Jamali A, Ciolino JB, Hamrah P. A randomized, sham-controlled trial of intraductal meibomian gland probing with or without topical antibiotic/steroid for obstructive meibomian gland dysfunction. Ocul Surf. 2020 Oct;18(4):852-856. doi: 10.1016/j.jtos.2020.08.008. Epub 2020 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'In this research study, the investigators are looking at the effects of Meibomian Gland Probing (MGP) versus a sham (fake) procedure in patients with refractory MGD who have already tried traditional management with no success in resolving their clinical signs (as seen by their ophthalmologist) or their symptoms.\n\nThe investigators are also evaluating the effects of using two (2) post-procedural medication treatments: Blephamide or GenTeal PM Night-Time to determine if treatment after the MGP procedure has an effect on its outcome.', 'detailedDescription': 'Dry eye disease is one of the most common conditions seen in ophthalmic practice and is associated with significant patient distress. Meibomian gland dysfunction (MGD) is among the most prevalent causes of dry eye disease. This condition, which is often due to obstruction of the meibomian gland orifices, may result in significant ocular irritation. Traditionally, management of MGD includes warm compress, lid hygiene, and anti-inflammatory medications. This randomized clinical trial is designed to evaluate the effects of meibomian gland probing versus sham procedure in cases with refractory MGD that do not respond to traditional treatments. Moreover, the effects of postoperative regimen will also be investigated using two different regimens. In addition to symptoms, the changes will also be evaluated in terms of clinical signs as well as in vivo confocal microscopy (IVCM) which allows study at the cellular level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-89 years\n* Willing and able to provide written informed consent\n* Willing and able to comply with study assessments for the full duration of the study\n* Diagnosis of meibomian gland dysfunction (MGD)\n* Symptoms of MGD such as foreign body sensation, burning, stinging, light sensitivity for at least 3 months\n* Persistent symptoms despite at least 3 months of medical management including lid hygiene, warm compress, and use of topical and systemic therapy, or contraindication to systemic therapy\n* Presence of lid tenderness on the upper lids in both eyes\n* Tear break-up time (TBUT) of \\<10 seconds\n* In good stable overall health\n\nExclusion Criteria:\n\n* Active allergies to steroids, sulfacetamide, GenTeal PM Night-Time ointment, or lidocaine\n* Intraocular surgery or ocular laser surgery within 1 month before enrollment\n* History of ocular infection within 1 month before enrollment.\n* History of increased intraocular pressure after using topical steroids (steroid responsive)\n* Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study"}, 'identificationModule': {'nctId': 'NCT02256969', 'acronym': 'MGP', 'briefTitle': 'Intraductal Meibomian Gland Probing Trial', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Prospective, Randomized Clinical Trial of Meibomian Gland Probing Versus Sham Procedure for Refractory Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': '14-059H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Meibomian Gland Probing plus lubricant', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nLubricant: GenTeal PM Night-Time Ointment (Alcon), a sterile ophthalmic lubricant that is commonly used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks with the following regimen: twice daily for 2 weeks and then once daily for 2 weeks.', 'interventionNames': ['Drug: GenTeal PM Night-Time', 'Procedure: Meibomian Gland Probing']}, {'type': 'OTHER', 'label': 'Sham Meibomian Gland Probing plus lubricant', 'description': "Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.\n\nLubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks.", 'interventionNames': ['Drug: GenTeal PM Night-Time', 'Procedure: Sham Meibomian Gland Probing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meibomian Gland Probing plus Blephamide', 'description': 'Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.\n\nBlephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks.', 'interventionNames': ['Drug: Blephamide', 'Procedure: Meibomian Gland Probing']}], 'interventions': [{'name': 'Blephamide', 'type': 'DRUG', 'otherNames': ['sulfacetamide sodium 10%/prednisolone acetate 0.2%, Allergan, Inc.'], 'armGroupLabels': ['Meibomian Gland Probing plus Blephamide']}, {'name': 'GenTeal PM Night-Time', 'type': 'DRUG', 'otherNames': ['GenTeal PM Night-Time Ophthalmic Ointment Alcon'], 'armGroupLabels': ['Meibomian Gland Probing plus lubricant', 'Sham Meibomian Gland Probing plus lubricant']}, {'name': 'Meibomian Gland Probing', 'type': 'PROCEDURE', 'description': 'For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. After obtaining adequate anesthesia, the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.', 'armGroupLabels': ['Meibomian Gland Probing plus Blephamide', 'Meibomian Gland Probing plus lubricant']}, {'name': 'Sham Meibomian Gland Probing', 'type': 'PROCEDURE', 'description': "For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.", 'armGroupLabels': ['Sham Meibomian Gland Probing plus lubricant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Joseph B Ciolino, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph B. Ciolino, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Joseph B. Ciolino, MD', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}