Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-09 @ 12:30 PM
Study NCT ID:
NCT00667004
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Sponsor:
Organization:
Raw JSON
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Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ecabet Ophthalmic Solution', 'description': 'ecabet ophthalmic solution\n\necabet ophthalmic solution: sterile ophthalmic solution'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Placebo comparator\n\nplacebo: sterile ophthalmic solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ecabet Ophthalmic Solution', 'description': 'ecabet ophthalmic solution\n\necabet ophthalmic solution: sterile ophthalmic solution'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Placebo comparator\n\nplacebo: sterile ophthalmic solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '14.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2011-09-02', 'completionDateStruct': {'date': '2008-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2008-04-23', 'dispFirstSubmitQcDate': '2011-09-02', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2008-04-24', 'dispFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2008-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test", 'timeFrame': '43 days', 'description': "The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'Efficacy study of ecabet ophthalmic solution in dry eye disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with dry eye disease\n\nExclusion Criteria:\n\n* Dry eye disease secondary to surgery'}, 'identificationModule': {'nctId': 'NCT00667004', 'briefTitle': 'Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'orgStudyIdInfo': {'id': 'CL-S&E-1107071-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ecabet ophthalmic solution', 'interventionNames': ['Drug: ecabet ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo comparator', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ecabet ophthalmic solution', 'type': 'DRUG', 'description': 'sterile ophthalmic solution', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'sterile ophthalmic solution', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'ISTA Pharmaceuticals, Inc.', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Tim McNamara, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ISTA Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}