Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-02 @ 11:46 AM
Study NCT ID:
NCT01783860
Status:
COMPLETED
Last Update Posted:
2014-02-12
First Post:
2013-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
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': 'D017963', 'term': 'Azithromycin'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bahmanik@eyeplasticsurgeries.com', 'phone': '00982166558811', 'title': 'Dr. Mohsen Bahmani-Kashkouli', 'organization': 'Rasoule-Akram Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'vomiting and loss of appetide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Blepharitis Symptoms Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change from the baseline until 61 days after treatment', 'description': 'Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Main Ocular Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline until 61 days after treatment', 'description': 'lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'zero time and 61 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change of Total Severity Score Between Baseline and 7 Days Later', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 7 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change of Total Severity Score Between Baseline and 31 Days Later', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 31 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change of Total Severity Score Between Baseline and 37 Days Later', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'OG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 37 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'FG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All 100 patients were selected from the eye clinic of Rasoule-Akram hospital during the study period. The patients were recruited sequentially.', 'preAssignmentDetails': 'Patients were excluded if they had: age\\< 12 years,history of ocular or lacrimal surgery,previous usage of contact lenses,history of ocular allergy or systemic diseases with ocular involvement, history of usage of topical or systemic antibiotic in the last month, pregnant or lactating mothers, liver failure and history of sensitivity to Cyclines.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month\n\nDoxycycline :'}, {'id': 'BG001', 'title': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.\n\nAzithromycin :'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-28', 'studyFirstSubmitDate': '2013-02-01', 'resultsFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-28', 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of Total Severity Score Between Baseline and 7 Days Later', 'timeFrame': 'baseline and 7 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.'}, {'measure': 'Change of Total Severity Score Between Baseline and 31 Days Later', 'timeFrame': 'baseline and 31 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.'}, {'measure': 'Change of Total Severity Score Between Baseline and 37 Days Later', 'timeFrame': 'baseline and 37 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.'}], 'primaryOutcomes': [{'measure': 'Change of Blepharitis Symptoms Score', 'timeFrame': 'Change from the baseline until 61 days after treatment', 'description': 'Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.'}, {'measure': 'Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score', 'timeFrame': 'zero time and 61 days later', 'description': 'Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.'}], 'secondaryOutcomes': [{'measure': 'Main Ocular Signs', 'timeFrame': 'Change from baseline until 61 days after treatment', 'description': 'lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Azithromycin', 'Doxycycline', 'Posterior Blepharitis'], 'conditions': ['Posterior Blepharitis']}, 'referencesModule': {'references': [{'pmid': '25138765', 'type': 'DERIVED', 'citation': 'Kashkouli MB, Fazel AJ, Kiavash V, Nojomi M, Ghiasian L. Oral azithromycin versus doxycycline in meibomian gland dysfunction: a randomised double-masked open-label clinical trial. Br J Ophthalmol. 2015 Feb;99(2):199-204. doi: 10.1136/bjophthalmol-2014-305410. Epub 2014 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'One hundred patients with the diagnosis of posterior blepharitis based on history taking and proper physical examinations by two experienced ophthalmologists will include in the study.\n\nPatients will diagnose with posterior blepharitis if they score at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria. Patients will exclude if they have the following criteria: age\\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines.\n\nQualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours for one month) in a double-blinded fashion. each patients in both treatment groups will accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes each in the treatment period. Symptoms and signs were recorded for each patient in two treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61 after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients were diagnosed with posterior blepharitis if they scored at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria\n\nExclusion Criteria:\n\nPatients were excluded if they had the following criteria: age\\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines'}, 'identificationModule': {'nctId': 'NCT01783860', 'briefTitle': 'Oral Azithromycin Versus Doxycycline in Posterior Blepharitis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Study of the Effect of Oral Azithromycin on Posterior Blepharitis', 'orgStudyIdInfo': {'id': '90-01-124-13076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Azithromycin', 'description': 'Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': 'Oral doxycycline 100mg capsule every 12 hours for one month', 'interventionNames': ['Drug: Doxycycline']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Azithromycin (Razak Co., Tehran)'], 'armGroupLabels': ['Oral Azithromycin']}, {'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Doxycycline (Kimidarou Co., Tehran)'], 'armGroupLabels': ['Doxycycline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14455-364', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Rassoul Akram Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Mohsen B Kashkouli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}