Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 9:19 PM
Study NCT ID:
NCT01109056
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', '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}}, 'adverseEventsModule': {'description': 'The Safety Population was used to calculate the number of participants at risk for SAEs and AEs, and is defined as all randomized and treated patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'otherNumAtRisk': 56, 'otherNumAffected': 19, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'otherNumAtRisk': 58, 'otherNumAffected': 16, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Instillation Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Ovarian Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}], 'seriousEvents': [{'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Pterygium Hyperemia Responders at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat:\n\nAll randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat:\n\nAll randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.2', 'spread': '16.97', 'groupId': 'OG000'}, {'value': '29.3', 'spread': '26.89', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 16', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '14.95', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '16.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclosporine Ophthalmic Emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-22', 'studyFirstSubmitDate': '2010-04-19', 'resultsFirstSubmitDate': '2012-05-22', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-22', 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Pterygium Hyperemia Responders at Week 16', 'timeFrame': 'Week 16', 'description': 'Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.'}, {'measure': 'Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pterygium']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a pterygium in at least one eye that has not been previously removed with surgery\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* Active eye disease\n* Current or anticipated use of topical eye medications other than artificial tears.\n* Anticipated wearing of contact lenses'}, 'identificationModule': {'nctId': 'NCT01109056', 'briefTitle': 'Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192371-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cyclosporine ophthalmic emulsion 0.05%', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'interventionNames': ['Drug: cyclosporine ophthalmic emulsion 0.05%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'cyclosporine ophthalmic emulsion 0.05%', 'type': 'DRUG', 'otherNames': ['RESTASIS®'], 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'armGroupLabels': ['cyclosporine ophthalmic emulsion 0.05%']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'One drop in the study eye (or eyes) administered four times daily (QID)', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}