Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04475432
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2020-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark@tarsusrx.com', 'phone': '408-431-6613', 'title': 'Mark Holdbrook, Senior Vice-President of Clinical Development', 'organization': 'Tarsus Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'It is specified in the protocol that the data generated in this clinical trial, all related information and any materials containing such data and information are the exclusive property of Tarsus Pharmaceuticals, Inc. and are confidential to Tarsus Pharmaceuticals. Also, the investigator or other study-related personnel may not disclose to anyone or use any data, information or materials related to this clinical trial without the express written consent of Tarsus Pharmaceuticals.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '57 days', 'description': 'Corresponds to the standard definition.', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day for approximately 43 days', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 37, 'seriousNumAtRisk': 212, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Control', 'description': 'Vehicle of TP-03 topical ophthalmic solution, administered twice a day for approximately 43 days', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 39, 'seriousNumAtRisk': 209, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Instillation site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular access site pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Cured Based on a Collarette Score at Day 43.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day'}, {'id': 'OG001', 'title': 'Control', 'description': 'Vehicle of TP-03 topical ophthalmic solution, administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.439', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '0.072', 'spread': '0.018', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '43 days', 'description': 'The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.', 'unitOfMeasure': 'Proportion cured', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day'}, {'id': 'OG001', 'title': 'Control', 'description': 'Vehicle of TP-03 ophthalmic solution, administered topically twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.677', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.173', 'spread': '0.026', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '43 days', 'description': 'The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values', 'unitOfMeasure': 'Proportion eradicated', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day'}, {'id': 'OG001', 'title': 'Control', 'description': 'Vehicle of TP-03 topical ophthalmic solution, administered twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.139', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.007', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '43 days', 'description': 'The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.', 'unitOfMeasure': 'Proportion cured', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day'}, {'id': 'FG001', 'title': 'Control', 'description': 'Vehicle of TP-03 topical ophthalmic solution, administered twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '203'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day'}, {'id': 'BG001', 'title': 'Control', 'description': 'Vehicle of TP-03 topical ophthalmic solution, administered twice a day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '12.09', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '12.63', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '12.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '396', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-25', 'size': 509729, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-28T01:40', 'hasProtocol': True}, {'date': '2021-05-26', 'size': 3603045, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-02T20:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active arm: TP-03 0.25%\n\nControl arm: Vehicle of TP-03'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'dispFirstSubmitDate': '2022-04-10', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-02', 'studyFirstSubmitDate': '2020-07-14', 'resultsFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2020-07-16', 'dispFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-02', 'studyFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Cured Based on a Collarette Score at Day 43.', 'timeFrame': '43 days', 'description': 'The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.'}], 'secondaryOutcomes': [{'measure': 'The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43', 'timeFrame': '43 days', 'description': 'The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values'}, {'measure': 'Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.', 'timeFrame': '43 days', 'description': 'The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43.\n\nThe primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Demodex'], 'conditions': ['Blepharitis']}, 'referencesModule': {'references': [{'pmid': '35965392', 'type': 'DERIVED', 'citation': 'Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner Ophthalmic Solution, 0.25%, for the Treatment of Demodex Blepharitis: Results of a Prospective, Randomized, Vehicle-Controlled, Double-Masked, Pivotal Trial (Saturn-1). Cornea. 2023 Apr 1;42(4):435-443. doi: 10.1097/ICO.0000000000003097. Epub 2022 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.', 'detailedDescription': 'This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol\n* Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash\n\nExclusion Criteria:\n\n* Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study\n* Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study\n* Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04475432', 'acronym': 'Saturn-1', 'briefTitle': 'Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tarsus Pharmaceuticals, Inc.'}, 'officialTitle': 'Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis', 'orgStudyIdInfo': {'id': 'TRS-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days', 'interventionNames': ['Drug: TP-03, 0.25%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days', 'interventionNames': ['Drug: TP-03 Vehicle']}], 'interventions': [{'name': 'TP-03, 0.25%', 'type': 'DRUG', 'otherNames': ['Lotilaner ophthalmic solution, 0.25%'], 'description': 'TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day', 'armGroupLabels': ['Active']}, {'name': 'TP-03 Vehicle', 'type': 'DRUG', 'description': 'Vehicle of TP-03 ophthalmic solution, administered twice a day', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea and Cataract Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Visionary Eye Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vision Institute', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '46290', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Cornea Associates, LLC', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Washburn Research LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Care Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27603', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculus Research, Inc at EyecareCenter', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vita Eye Clinic', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, P.A.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'facility': 'Alpine Research Organization', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}], 'overallOfficials': [{'name': 'David Wirta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Research Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarsus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}