Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00717418
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2008-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President, GHOSR', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to actual dry eye treatment used, data were not interpretable by separate treatment arms. Hence, Outcomes are only reported as a single group.'}}, 'adverseEventsModule': {'description': 'Serious adverse events and adverse events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Surface Disease Index (OSDI) Total Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients'}], 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '22.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Schirmer's Test With and Without Anesthesia at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients'}], 'classes': [{'title': "Schirmer's Test with Anesthesia", 'categories': [{'measurements': [{'value': '8.1', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': "Schirmer's Test without Anesthesia", 'categories': [{'measurements': [{'value': '9.6', 'spread': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.", 'unitOfMeasure': 'millimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat, which included all patients who started the study (completed baseline visit).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Restasis® Alone', 'description': 'cyclosporine ophthalmic emulsion 0.05%'}, {'id': 'FG001', 'title': 'Artificial Tears Alone'}, {'id': 'FG002', 'title': 'Combination Treatments'}, {'id': 'FG003', 'title': 'Missing Treatment Information'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '508'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '508'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}]}]}, {'title': '1-Year Follow-Up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '508'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '434'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Treatment for this study was per normal clinical practice and not assigned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '508', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '781', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Restasis® Alone', 'description': 'cyclosporine ophthalmic emulsion 0.05%'}, {'id': 'BG001', 'title': 'Artificial Tears Alone'}, {'id': 'BG002', 'title': 'Combination Treatments'}, {'id': 'BG003', 'title': 'Missing Treatment Information'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '91'}, {'value': '64.5', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '87'}, {'value': '60.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '96'}, {'value': '61.0', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '87'}, {'value': '60.0', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '627', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 781}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2008-07-14', 'resultsFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-05', 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Schirmer's Test With and Without Anesthesia at Baseline", 'timeFrame': 'Baseline', 'description': "Schirmer's Test with and without anesthesia at baseline. The Schirmer's test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production."}], 'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index (OSDI) Total Score at Baseline', 'timeFrame': 'Baseline', 'description': 'The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).'}]}, 'conditionsModule': {'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients can either:\n\n1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment\n2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of dry eye disease\n* Currently using artificial tears daily\n* Male or female of legal age of consent\n* Normal lid position and closure\n\nExclusion Criteria\n\n* Patients currently using cyclosporine ophthalmic emulsion 0.05%\n* Participation in other investigational drug or device study\n* Any current or previous topical ophthalmic or oral cyclosporine use within the last three years'}, 'identificationModule': {'nctId': 'NCT00717418', 'briefTitle': 'Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'R.E.S.T.O.R.E.'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '* cyclosporine ophthalmic emulsion 0.05%\n* artificial tears', 'interventionNames': ['Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears']}], 'interventions': [{'name': 'cyclosporine ophthalmic emulsion 0.05%, artificial tears', 'type': 'DRUG', 'otherNames': ['Restasis®'], 'description': 'one drop, twice a day in each eye', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wilson', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.72127, 'lon': -77.91554}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}