Viewing Study NCT02188160


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Study NCT ID: NCT02188160
Status: COMPLETED
Last Update Posted: 2021-01-06
First Post: 2014-07-09
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D006940', 'term': 'Hyperemia'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'results002@kalarx.com', 'phone': '781-996-5252', 'title': 'VP, Clinical Development', 'organization': 'Kala Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The institution and Investigators participating in this trial shall have no right to publish or present the results of this study without the prior written consent of the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from Visit 2 (Day 1) through Visit 6 (Day 29).', 'description': 'One Subject was randomized to KPI-121 0.25% but received vehicle. Therefore, 72 subjects are included in the KPI-121 0.25% group and 78 subjects are included in the vehicle group in the safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 7, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 8, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 16, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1.'}], 'seriousEvents': [{'term': 'Cholelithiasis', 'notes': 'One subject reported an SAE (cholelithiasis; KPI-121 0.25% group), which was considered unrelated to the study treatment; it was severe in intensity, led the subject to discontinue the study treatment, and ultimately resolved without sequelae.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.1.'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bulbar Conjunctival Hyperemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.633', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '0.626', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 6 (Day 29)', 'description': 'Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Ocular Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.05', 'spread': '23.892', 'groupId': 'OG000'}, {'value': '60.47', 'spread': '19.770', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 6 (Day 29)', 'description': 'Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Corneal Fluorescein Staining Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'classes': [{'title': 'Visit 4 (Day 15)', 'categories': [{'measurements': [{'value': '6.15', 'spread': '2.582', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '2.920', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 (Day 29)', 'categories': [{'measurements': [{'value': '5.64', 'spread': '2.889', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '3.445', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Day 15) and Visit 6 (Day 29)', 'description': 'Comparison of mean corneal fluorescein staining scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Bulbar Conjunctival Hyperemia Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '0.586', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.676', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Day 15)', 'description': 'Comparison of mean bulbar conjunctival hyperemia scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Ocular Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.83', 'spread': '20.745', 'groupId': 'OG000'}, {'value': '63.63', 'spread': '17.844', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 4 (Day 15)', 'description': 'Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Use of an excluded medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease\n\nKPI-121: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease\n\nPlacebo: Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '17.17', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '12.29', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '14.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-09-26', 'size': 1710099, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-25T13:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2016-07-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2014-07-09', 'dispFirstSubmitQcDate': '2016-07-08', 'resultsFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2014-07-10', 'dispFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-04', 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bulbar Conjunctival Hyperemia', 'timeFrame': 'Visit 6 (Day 29)', 'description': 'Comparison of mean bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.'}, {'measure': 'Ocular Discomfort', 'timeFrame': 'Visit 6 (Day 29)', 'description': 'Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.'}], 'secondaryOutcomes': [{'measure': 'Corneal Fluorescein Staining Scores', 'timeFrame': 'Visit 4 (Day 15) and Visit 6 (Day 29)', 'description': 'Comparison of mean corneal fluorescein staining scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. The total score is obtained by summing each of the 5 sections of the cornea. The NEI score will be from 0-15.'}, {'measure': 'Bulbar Conjunctival Hyperemia Scores', 'timeFrame': 'Visit 4 (Day 15)', 'description': 'Comparison of mean bulbar conjunctival hyperemia scores in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.'}, {'measure': 'Ocular Discomfort', 'timeFrame': 'Visit 4 (Day 15)', 'description': 'Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Corticosteroid', 'Dry Eye', 'Hyperemia', 'Ocular Discomfort'], 'conditions': ['Dry Eye Syndromes', 'Keratoconjunctivitis Sicca']}, 'referencesModule': {'references': [{'pmid': '32826644', 'type': 'DERIVED', 'citation': 'Korenfeld M, Nichols KK, Goldberg D, Evans D, Sall K, Foulks G, Coultas S, Brazzell K. Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies. Cornea. 2021 May 1;40(5):564-570. doi: 10.1097/ICO.0000000000002452.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).', 'detailedDescription': 'This is a Phase II, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.\n\nApproximately 400 subjects will be screened and up to 150 subjects will be randomized at up to 12 centers located in the United States. Subjects will be randomized to 1 of 2 study arms in an approximate 1:1 ratio. The study arms are: 1) KPI-121 0.25% ophthalmic suspension administered 1-2 drops in each eye QID for up to 28 days or 2) vehicle administered as 1-2 drops in each eye QID for up to 28 days.\n\nThis study will include up to 6 clinic visits over 6 weeks. At Visit 1 Screening (14 ± 1 days prior to Day 1), subjects who meet screening inclusion/exclusion criteria will begin a 2-week run-in period during which they will be treated with 1-2 drops of single-masked vehicle in each eye QID for 14 ± 1 days.\n\nAt Visit 2, Randomization (Day 1), subjects who continue to meet inclusion/exclusion criteria will be eligible for randomization to 1 of the 2 arms of the study (i.e., KPI-121 0.25% ophthalmic suspension or vehicle). Following randomization, subjects will be instructed to return to the clinic to have a complete study evaluation at Study Visits 4 and 6 (Days 15 ± 1 day and 29 ± 1 day, respectively). Subjects will further be instructed to return to the clinic for diary collection and in-clinic symptom assessment only at Visits 3 and 5 (Days 8 ± 1 day and 22 ± 1 day, respectively). The last dose of investigational product and the final study visit will occur upon completion of 28 ± 1 days of exposure to investigational product. Subjects will be released from the study at the end of Visit 6 (Day 29 ± 1 day).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Have a documented clinical diagnosis of dry eye disease in both eyes\n\nExclusion Criteria:\n\n* Known hypersensitivity/contraindication to study product(s) or components.\n* History of glaucoma, IOP \\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.\n* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.\n* In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.'}, 'identificationModule': {'nctId': 'NCT02188160', 'acronym': 'Kauai', 'briefTitle': 'Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kala Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease', 'orgStudyIdInfo': {'id': 'KPI-121-C-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KPI-121 0.25% Ophthalmic Suspension', 'description': 'KPI-121 0.25% ophthalmic suspension dosed QID for 28 days in subjects with dry eye disease', 'interventionNames': ['Drug: KPI-121']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle (placebo) dosed QID for 28 days in subjects with dry eye disease', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KPI-121', 'type': 'DRUG', 'otherNames': ['KPI-121 0.25% Ophthalmic Suspension', 'Loteprednol etabonate'], 'description': 'KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.', 'armGroupLabels': ['KPI-121 0.25% Ophthalmic Suspension']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle of KPI-121 0.25% Ophthalmic Suspension'], 'description': 'Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Research Medical Center', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'North Valley Eye Medical Group', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eye Center of Southern CT, P.C.', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Price Vision Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '11793', 'city': 'Wantagh', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore Eye Center, LLP', 'geoPoint': {'lat': 40.68371, 'lon': -73.51013}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Abrams Eye Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77055', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Whitsett Vision Group', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Gregg Berdy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Associates'}, {'name': 'David Evans, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Total Eye Care, PA'}, {'name': 'Kathy Kelley, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Price Vision Group'}, {'name': 'Joseph Martel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Martel Eye Medical Group'}, {'name': 'Mark Milner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Center of Southern CT, P.C.'}, {'name': 'Steven Rauchman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Valley Eye Medical Group'}, {'name': 'Kenneth Sall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sall Research Medical Center'}, {'name': 'Jeffrey Whitsett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Whitsett Vision Group'}, {'name': 'Marc Abrams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abrams Eye Center'}, {'name': 'Michael Korenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC'}, {'name': 'Jodi Luchs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Shore Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kala Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}