[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633773":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":34,"studyPopulation":24,"armGroups":35,"interventions":47,"overallOfficials":58,"centralContacts":63,"locations":69,"responsibleParty":83,"collaborators":24,"id":85,"slug":24,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":24,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":24,"enrollmentInfo":93,"targetDuration":24,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Alcon Research","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2)","Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.","Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)",{"measure":14,"description":11,"timeFrame":15},"Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3)","Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)",[17,21],{"measure":18,"description":19,"timeFrame":20},"Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2)","Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).","Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)",{"measure":22,"description":19,"timeFrame":23},"Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3)","Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":31},"DOUBLE",[32,33],"PARTICIPANT","INVESTIGATOR","Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free","EXPERIMENTAL","One drop in each eye on Day 1 (single dose)",[41],"Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free",{"label":43,"type":44,"description":39,"interventionNames":45},"Vehicle","PLACEBO_COMPARATOR",[46],"Drug: Vehicle",[48,55],{"type":49,"name":37,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation",[37],[53,54],"FID 123472","Apraclonidine 0.125% UDPF",{"type":49,"name":43,"description":56,"armGroupLabels":57,"otherNames":24},"Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation",[43],[59],{"name":60,"affiliation":61,"role":62},"Clinical Trial Lead, Pharma","Alcon Research, LLC","STUDY_DIRECTOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":24,"email":68},"Alcon Call Center","CONTACT","1-888-451-3937","alcon.medinfo@alcon.com",[70],{"facility":71,"status":24,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":24},"Contact Alcon Call Center for Trial Locations","Fort Worth","Texas","76134","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-97.32085,32.72541,{"lat":81,"lon":80},{"type":84,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100633773",false,"NCT07531043","Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults","A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness","Key Inclusion Criteria:\n\n* Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.\n* Willing and able to follow all instructions and attend all study visits.\n* History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.\n* Baseline investigator-assessed ocular redness score of greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2).\n* Other protocol-defined inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.\n* Ocular surgical intervention within 6 months prior to Visit 1 or during the study.\n* Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.\n* Use of any of the prohibited medications or devices as specified in the study protocol.\n* Out-of-range vital signs (blood pressure and\u002For pulse rate) as defined in the study protocol.\n* Abnormal intraocular pressure.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years",{"count":94,"type":95},230,"ESTIMATED","INTERVENTIONAL",[98],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.",[101],"Ocular Hyperemia",[103],"Ocular Redness","NOT_YET_RECRUITING","2026-06-08",{"date":107,"type":108},"2026-06-10","ACTUAL",{"date":110,"type":95},"2026-10",{"date":112,"type":95},"2027-02",{"name":5,"class":6},1]