[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657514":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":23,"interventions":36,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":45,"collaborators":13,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":13,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":13,"enrollmentInfo":57,"targetDuration":13,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":13,"overallStatus":66,"whyStopped":13,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":13},{"fullName":5,"class":6},"Laboratoires Thea","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Corneal Endothelial Cell Density Change From Baseline to Day 90","The primary endpoint is the mean change from baseline in the number\u002Fdensity of corneal endothelial cells 90 days post treatment with articaine ophthalmic solution or placebo.","Baseline and Day 90 post-IP administration",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","OTHER",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Articaine ophthalmic solution (CYKLX)","EXPERIMENTAL","The participant will be administered of Articaine ophthalmic solution",[29],"Drug: Articaine (CYKLX)",{"label":31,"type":32,"description":33,"interventionNames":34},"Vehicle","PLACEBO_COMPARATOR","The participant will be administered of vehicle ophthalmic solution (without active substance).",[35],"Drug: Vehicle",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DRUG","Articaine (CYKLX)","Two drops of Articaine administered sequentially to the study eye.",[25],{"type":38,"name":31,"description":43,"armGroupLabels":44,"otherNames":13},"Two drops of Vehicle administered sequentially to the study eye.",[31],{"type":46,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100657514","phase-4-evaluation-of-corneal-endothelium-health-following-articaine-ophthalmic-solution-administration-100657514",false,"NCT07838129","Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration","A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Corneal Endothelium Health of Eyes Treated With Articaine Ophthalmic Solution, or Placebo","Inclusion Criteria:\n\n* Able to voluntarily provide written informed consent to participate in the study.\n* In the Investigator's opinion, generally healthy and free from significant medical or ocular conditions.\n\nExclusion Criteria:\n\n* History of ocular surgery (extraocular or intraocular) in either eye within 6 months prior to Screening Visit 1.\n* History of intravitreal injection in either eye within 14 days prior to Visit 2.",true,"ALL","18 Years",{"count":58,"type":59},165,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.",[65],"Healthy Cornea","NOT_YET_RECRUITING","2026-09-18",{"date":69,"type":70},"2026-09-24","ACTUAL",{"date":72,"type":59},"2027-01",{"date":74,"type":59},"2027-12",{"name":5,"class":6}]