Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-28 @ 7:27 PM
Study NCT ID:
NCT00379834
Status:
COMPLETED
Last Update Posted:
2015-02-10
First Post:
2006-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
12-Month Stability of Diurnal IOP Control on Cosopt
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479140', 'term': 'dorzolamide-timolol combination'}, {'id': 'C062765', 'term': 'dorzolamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'realinia@wvuhealthcare.com', 'phone': '3045986926', 'title': 'Dr. Tony Realini', 'organization': 'West Virginia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Cosopt', 'description': 'Cosopt twice daily in both eyes', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diurnal Intraocular Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cosopt', 'description': 'Cosopt twice daily in both eyes'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Selected by level funding available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cosopt', 'description': 'Cosopt BID OU'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Time constraints', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '10 subjects enrolled from WVU Eye Institute between April 2006 and April 2008', 'preAssignmentDetails': 'No patients excluded at any time'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cosopt', 'description': 'Cosopt BID OU'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2006-09-21', 'resultsFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-26', 'studyFirstPostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diurnal Intraocular Pressure Control', 'timeFrame': '12 months', 'description': 'Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'diurnal', 'intraocular pressure'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt', 'detailedDescription': 'Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral open-angle glaucoma\n\nExclusion Criteria:\n\n* contraindications to Cosopt\n* pathology affecting tonometry'}, 'identificationModule': {'nctId': 'NCT00379834', 'briefTitle': '12-Month Stability of Diurnal IOP Control on Cosopt', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': '12-Month Stability of Diurnal IOP Control on Cosopt', 'orgStudyIdInfo': {'id': '31861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cosopt', 'description': 'Cosopt twice daily in both eyes', 'interventionNames': ['Drug: Cosopt']}], 'interventions': [{'name': 'Cosopt', 'type': 'DRUG', 'otherNames': ['Dorzolamide/timolol fixed combination'], 'description': 'Cosopt twice daily in both eyes', 'armGroupLabels': ['Cosopt']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anthony D Realini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anthony D. Realini', 'investigatorAffiliation': 'West Virginia University'}}}}