Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 11:43 PM
Study NCT ID:
NCT02688556
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2016-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], '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': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'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': 'clinical.trials@sparcmail.com', 'phone': '+912266455645', 'title': 'SPARC', 'organization': 'Sun Pharma Advanced Research Company Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution.\n\nA total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09%', 'otherNumAtRisk': 372, 'deathsNumAtRisk': 372, 'otherNumAffected': 130, 'seriousNumAtRisk': 372, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101\n\nA total of 744 subjects were included in the Safety population, with 372 subjects in the OTX-101 0.09% group and 372 subjects in the Vehicle group. The only difference between the ITT and the Safety populations is that Subject 14-003 was analyzed in the Safety population according to the treatment received, which was OTX-101 0.09%', 'otherNumAtRisk': 372, 'deathsNumAtRisk': 372, 'otherNumAffected': 66, 'seriousNumAtRisk': 372, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation site lacrimation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Instillation site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 372, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perforated ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 372, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 372, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tear Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': "Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score", 'unitOfMeasure': 'Percentage of eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Conjunctival Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.53', 'spread': '1.927', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '2.2064', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.\n\nConjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Central Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.533', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.588', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.\n\nThe Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.8', 'spread': '24.08', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '23.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.\n\nA modified SANDE instrument was used to evaluate dry eye symptoms at each visit.\n\nSubjects were asked to indicate:\n\n1. frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and\n2. severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)\n\nNegative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '373'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '347'}, {'groupId': 'FG001', 'numSubjects': '361'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'preAssignmentDetails': 'One subject in OTX-101 0.09% group, was never treated with study medication and is not included in any of analysis sets Additionally, because the subjects in the ITT analysis set were analyzed as randomized, one subject who erroneously received OTX-101 0.09%, was included in the Vehicle group for purposes of efficacy analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '373', 'groupId': 'BG001'}, {'value': '744', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'vehicle of OTX-101'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '14.10', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '14.68', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '14.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', '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'}], 'populationDescription': 'Intent to treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-26', 'studyFirstSubmitDate': '2016-02-13', 'resultsFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-05', 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Production', 'timeFrame': 'Baseline and 12 weeks', 'description': "Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score"}], 'secondaryOutcomes': [{'measure': 'Conjunctival Staining', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.\n\nConjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)'}, {'measure': 'Central Corneal Staining', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.\n\nThe Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.'}, {'measure': 'Symptom Score', 'timeFrame': 'Baseline and 12 weeks', 'description': 'change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.\n\nA modified SANDE instrument was used to evaluate dry eye symptoms at each visit.\n\nSubjects were asked to indicate:\n\n1. frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and\n2. severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)\n\nNegative change from baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['KCS', 'dry eye', 'cyclosporine'], 'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* History of dry eye syndrome (KCS) for a period of at least 6 months\n* Clinical diagnosis of bilateral KCS\n* Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.\n* Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits\n* Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.\n\nExclusion Criteria:\n\n* Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.\n* Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).\n* Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.\n* Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.\n* Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.\n* Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.\n* Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).\n* History of herpes keratitis.\n* Corneal transplant\n* Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.\n* Cataract surgery within 3 months prior to the Screening Visit."}, 'identificationModule': {'nctId': 'NCT02688556', 'acronym': 'Emerald', 'briefTitle': 'Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca', 'orgStudyIdInfo': {'id': 'OTX-101-2016-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OTX-101 0.09%', 'description': '0.09% cyclosporine nanomicellar ophthalmic solution', 'interventionNames': ['Drug: cyclosporine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'vehicle of OTX-101', 'interventionNames': ['Drug: vehicle of OTX-101']}], 'interventions': [{'name': 'cyclosporine', 'type': 'DRUG', 'otherNames': ['Seciera'], 'armGroupLabels': ['OTX-101 0.09%']}, {'name': 'vehicle of OTX-101', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Fifth Avenue Eye Associates', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}