Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 4:35 AM
Study NCT ID:
NCT07443202
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711088', 'term': 'lotilaner'}]}}, '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': 'ESTIMATED', 'count': 155}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Telangiectasia', 'timeFrame': 'Week 16', 'description': 'Grading of telangiectasia'}, {'measure': 'Erythema', 'timeFrame': 'Week 16', 'description': 'Grading of erythema'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment Emergent Adverse Events', 'timeFrame': 'Week 16', 'description': 'Number of patients with treatment related emergent adverse events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'Week 16', 'description': 'Measurement of intraocular pressure'}, {'measure': 'Visual acuity', 'timeFrame': 'Week 16', 'description': 'Measurement of visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Rosacea']}, 'descriptionModule': {'briefSummary': 'To evaluate lotilaner treatment in patients with ocular rosacea.', 'detailedDescription': 'To evaluate safety of lotilaner compared to vehicle control in the treatment of ocular rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at the time of consent.\n* Has moderate to severe ocular rosacea\n* Use of acceptable methods of contraception\n* Are willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Patient taking a topical or other therapy which may affect the patients rosacea\n* Actively managed glaucoma or active ocular infection or ocular systemic disease\n* Have hypersensitivity to lotilaner or any of the formulation components\n* Are currently enrolled in an investigational drug or device study\n* Are currently pregnant or lactating or planning to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT07443202', 'briefTitle': 'Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tarsus Pharmaceuticals, Inc.'}, 'officialTitle': 'A Randomized, Vehicle-Controlled, Multicenter, Double-Masked, Parallel, Phase 2 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of Lotilaner Ophthalmic Gel in Participants With Ocular Rosacea (KORE)', 'orgStudyIdInfo': {'id': 'TRS-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'lotilaner - high dose and low dose', 'interventionNames': ['Drug: lotilaner']}, {'type': 'OTHER', 'label': 'Control arm', 'description': 'Vehicle of lotilaner - high dose and low dose', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'lotilaner', 'type': 'DRUG', 'description': 'lotilaner', 'armGroupLabels': ['Treatment arm']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Vehicle of lotilaner', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tarsus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}