Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-06 @ 2:22 PM
Study NCT ID:
NCT02617667
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D005079', 'term': 'Excipients'}], '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'}, {'id': 'D014677', 'term': 'Pharmaceutical Vehicles'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+49 6221 50259-0', 'title': 'Dr Sonja Krösser, VP Preclinical and Clinical Development', 'organization': 'Novaliq GmbH'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events reported were documented from the first dose of randomized study drug until the end of the last study day visit (day 113)', 'eventGroups': [{'id': 'EG000', 'title': 'CyclASol 0.05% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'CyclASol 0.1% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 4, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo Ophthalmic Solution', 'description': 'Blinded treatment arm. Vehicle only Topical ocular eye drops.\n\n1 drop in each eye, twice daily.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 4, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Restasis', 'description': 'Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.\n\n1 drop in each eye, twice daily.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 4, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CyclASol 0.05% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'OG001', 'title': 'CyclASol 0.1% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'OG002', 'title': 'Placebo Ophthalmic Solution', 'description': 'Blinded treatment arm. Vehicle only. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.38', 'spread': '2.156', 'groupId': 'OG000'}, {'value': '-2.10', 'spread': '2.252', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '2.619', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 113 Days', 'description': 'The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was selected as the worst eye.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CyclASol 0.05% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'OG001', 'title': 'CyclASol 0.1% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'OG002', 'title': 'Placebo Ophthalmic Solution', 'description': 'Blinded treatment arm. Vehicle only. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.00', 'spread': '19.362', 'groupId': 'OG000'}, {'value': '-9.30', 'spread': '27.832', 'groupId': 'OG001'}, {'value': '-13.85', 'spread': '25.301', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 113 Days', 'description': 'The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was taken.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CyclASol 0.05% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily'}, {'id': 'FG001', 'title': 'CyclASol 0.1% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'FG002', 'title': 'Placebo Ophthalmic Solution', 'description': 'Blinded treatment arm. Vehicle only. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'FG003', 'title': 'Restasis', 'description': 'Active comparator, open label arm. Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'CyclASol 0.05% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.05%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'BG001', 'title': 'CyclASol 0.1% Ophthalmic Solution', 'description': 'Blinded treatment arm. Cyclosporine A solution (0.1%) in vehicle. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'BG002', 'title': 'Placebo Ophthalmic Solution', 'description': 'Blinded treatment arm. Vehicle only. Topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'BG003', 'title': 'Restasis', 'description': 'Active comparator, open label arm . Cyclosporine A 0.05% ophthalmic emulsion topical ocular eye drops.\n\n1 drop in each eye, twice daily.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '10.72', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '12.29', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '10.45', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '11.20', 'groupId': 'BG003'}, {'value': '62.4', 'spread': '11.36', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set included all randomized participants.'}}, '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': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2015-11-25', 'resultsFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-27', 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days', 'timeFrame': 'Baseline to 113 Days', 'description': 'The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.'}, {'measure': 'Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days', 'timeFrame': 'Baseline to 113 Days', 'description': 'The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'referencesModule': {'references': [{'pmid': '30703441', 'type': 'RESULT', 'citation': 'Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GW, Steven P, Krosser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800. doi: 10.1016/j.ophtha.2019.01.024. Epub 2019 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).', 'detailedDescription': 'This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included.\n\nThe study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED.\n\nThe primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document\n* Patient-reported history of dry eye in both eyes\n* Current use of over-the-counter and/or prescription eye drops for dry eye symptoms\n* Ability and willingness to follow instructions, including participation in all study assessments and visits\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or planning a pregnancy\n* Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control\n* Clinically significant slit-lamp findings or abnormal lid anatomy at screening\n* DED secondary to scarring or ocular or periocular malignancy\n* History of herpetic keratitis\n* Active ocular allergies or ocular allergies that are expected to be active during the study period\n* Ongoing ocular or systemic infection at screening or baseline\n* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study\n* History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening\n* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period\n* Presence of an uncontrolled systemic disease\n* Presence of a known allergy and/or sensitivity to the study drug or its components'}, 'identificationModule': {'nctId': 'NCT02617667', 'briefTitle': 'CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novaliq GmbH'}, 'officialTitle': 'A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease', 'orgStudyIdInfo': {'id': 'CYS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CyclASol Ophthalmic Solution 1', 'description': 'Cyclosporine A solution (dose-level 1) in vehicle', 'interventionNames': ['Drug: Cyclosporine A']}, {'type': 'EXPERIMENTAL', 'label': 'CyclASol Ophthalmic Solution 2', 'description': 'Cyclosporine A solution (dose-level 2) in vehicle', 'interventionNames': ['Drug: Cyclosporine A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Ophthalmic Solution', 'description': 'Vehicle only', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis', 'description': 'Cyclosporine A 0.05% ophthalmic emulsion', 'interventionNames': ['Drug: Cyclosporine A']}], 'interventions': [{'name': 'Cyclosporine A', 'type': 'DRUG', 'otherNames': ['Ciclosporin, CsA'], 'description': 'topical ocular, eye drops', 'armGroupLabels': ['CyclASol Ophthalmic Solution 1', 'CyclASol Ophthalmic Solution 2', 'Restasis']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Excipient'], 'description': 'topical ocular, eye drops', 'armGroupLabels': ['Placebo Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'CYS-002 Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '04240', 'city': 'Lewiston', 'state': 'Maine', 'country': 'United States', 'facility': 'CYS-002 Investigational Site', 'geoPoint': {'lat': 44.10035, 'lon': -70.21478}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CYS-002 Investigational Site', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'CYS-002 Investigational Site', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}], 'overallOfficials': [{'name': 'Sonja Kroesser, Dr.sc.hum.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novaliq GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novaliq GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}