[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07443202":3,"trial-entities:NCT07443202":91,"trial-summary:NCT07443202":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":67,"locations":70,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT07443202","TRS-030","Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)","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)","ENROLLING_BY_INVITATION","2027-12-31","2026-02","2026-03-02","2025-12-05","Tarsus Pharmaceuticals, Inc.","INDUSTRY",false,"To evaluate lotilaner treatment in patients with ocular rosacea.","To evaluate safety of lotilaner compared to vehicle control in the treatment of ocular rosacea.",[19],"Ocular Rosacea",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},155,"ESTIMATED",[29,34],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DRUG","lotilaner",[33],"Treatment arm",{"type":30,"name":35,"description":36,"armGroupLabels":37},"Vehicle","Vehicle of lotilaner",[38],"Control arm",[40],{"measure":41,"description":42,"timeFrame":43},"Incidence of Treatment Emergent Adverse Events","Number of patients with treatment related emergent adverse events (TEAEs)","Week 16",[45,48],{"measure":46,"description":47,"timeFrame":43},"Intraocular pressure","Measurement of intraocular pressure",{"measure":49,"description":50,"timeFrame":43},"Visual acuity","Measurement of visual acuity","ALL","18 Years",null,{"inclusion":55,"exclusion":60,"raw_text":66},[56,57,58,59],"18 years of age or older at the time of consent.","Has moderate to severe ocular rosacea","Use of acceptable methods of contraception","Are willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol",[61,62,63,64,65],"Patient taking a topical or other therapy which may affect the patients rosacea","Actively managed glaucoma or active ocular infection or ocular systemic disease","Have hypersensitivity to lotilaner or any of the formulation components","Are currently enrolled in an investigational drug or device study","Are currently pregnant or lactating or planning to become pregnant during the study","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",[68,69],"ADULT","OLDER_ADULT",[71,80],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"Site","Houston","Texas","77027","United States",{"lat":78,"lon":79},29.76328,-95.36327,{"facility":72,"city":81,"state":82,"zip":83,"country":76,"geoPoint":84},"Lynchburg","Virginia","24502",{"lat":85,"lon":86},37.41375,-79.14225,[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Ocular rosacea",[],{"nct_id":4,"found":15,"summary":53,"prompt_version":53}]