Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT00631358
Status:
COMPLETED
Last Update Posted:
2010-04-12
First Post:
2008-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '1-888-451-3937; 1-817-568-6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Labs'}, 'certainAgreement': {'otherDetails': 'The sponsor shall be furnished with copies of any proposed disclosure as follows: Published abstracts will be submitted to the sponsor one month prior to submission allowing the sponsor three weeks to respond. Presentations will be submitted to the sponsor one moth prior to submission allowing the sponsor three weeks to respond. Publications will be submitted to the sponsor two months prior to submission allowing the sponsor two months to respond.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse reporting began once the patient enrolled into the study and went on for the duration of the study (6 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Levels of Biomarkers After Dosing With Maxidex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '-1.244', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '2 weeks', 'categories': [{'measurements': [{'value': '-0.033', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.', 'unitOfMeasure': 'ddCt (Delta-Delta-Ct)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between Biomarker Expression and Ocular Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000'}, {'value': '-0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).', 'unitOfMeasure': 'Correlation factor', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between Biomarker Expression and Tear Film Break up Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000'}, {'value': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor:\n\nTNFmRNA vs. TFBUT (Tear Film Break-up Time)', 'unitOfMeasure': 'Correlation factor', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor:\n\nTNFmRNA vs. NaFl staining', 'unitOfMeasure': 'Correlation factor', 'reportingStatus': 'POSTED', 'populationDescription': 'No data available for the no treatment group.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Biomarker Expression and the Schirmer Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000'}, {'value': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor: TNFmRNA vs. Schirmer', 'unitOfMeasure': 'Correlation Factor', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'FG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "Patients were recruited via flyers, newspaper advertisements, radio advertisements and chart review in the doctors' office."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Maxidex', 'description': 'Maxidex 1 drop in each eye 2 times daily'}, {'id': 'BG001', 'title': 'No Treatment', 'description': 'Healthy normal control group receiving no treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-03-29', 'studyFirstSubmitDate': '2008-02-29', 'resultsFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2008-02-29', 'lastUpdatePostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-29', 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Levels of Biomarkers After Dosing With Maxidex', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Biomarker Expression and Ocular Symptoms', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).'}, {'measure': 'Correlation Between Biomarker Expression and Tear Film Break up Time', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor:\n\nTNFmRNA vs. TFBUT (Tear Film Break-up Time)'}, {'measure': 'Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor:\n\nTNFmRNA vs. NaFl staining'}, {'measure': 'Correlation Between Biomarker Expression and the Schirmer Test', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Correlation factor: TNFmRNA vs. Schirmer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ocular inflammation'], 'conditions': ["Sjogren's Syndrome"]}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria of Sjorgren's Population:\n\nInclusion Criteria:\n\n* 17 years or older\n* LogMar visual acuity of 0.6 or better\n* Ocular inflammation associated with Sjogren's Syndrome\n\nExclusion Criteria:\n\n* Has had an adverse reaction to either topical of systemic steroids in the past\n* Has diabetes (type 1 or 2)\n* Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1\n* Has worn contact lenses within one week prior to Visit 1\n* Has received ocular prescription therapy in the last 30 days\n* Has active ocular infections or inflammation not associated with Sjogren's Syndrome.\n* Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant"}, 'identificationModule': {'nctId': 'NCT00631358', 'briefTitle': "Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention", 'nctIdAliases': ['NCT00806702'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'ORE 14351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maxidex', 'description': 'Maxidex', 'interventionNames': ['Drug: Maxidex']}, {'type': 'SHAM_COMPARATOR', 'label': 'No treatment', 'description': 'Healthy normal control group receiving no treatment', 'interventionNames': ['Other: No treatment']}], 'interventions': [{'name': 'Maxidex', 'type': 'DRUG', 'description': 'Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily', 'armGroupLabels': ['Maxidex']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'Healthy normal control group receiving no treatment', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Waterloo', 'country': 'Canada', 'facility': 'Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ravaughn Williams, OD, MS', 'oldOrganization': 'Alcon'}}}}