[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620199":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":33,"studyPopulation":20,"armGroups":34,"interventions":47,"overallOfficials":60,"centralContacts":64,"locations":73,"responsibleParty":88,"collaborators":20,"id":90,"slug":20,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":20,"enrollmentInfo":99,"targetDuration":20,"studyType":102,"phases":103,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Qlaris Bio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in IOP","Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.","Over 15 days",[14,17],{"measure":15,"description":16,"timeFrame":12},"Ocular safety and tolerability","Incidence of ocular adverse events",{"measure":18,"description":19,"timeFrame":12},"Ocular comfort","Ocular comfort following study treatment as assessed by subject and using a visual analog scale (VAS) provided by the site at the treatment period visits. Subjects will grade their ocular comfort on a scale of 0 (extremely comfortable) to 100 (extremely uncomfortable) by placing a vertical mark on the horizontal line.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":27,"whoMasked":28},"QUADRUPLE","IP is packaged and labeled in a masked fashion",[29,30,31,32],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"QLS-111-FDC ophthalmic solution","EXPERIMENTAL","QLS-111-FDC, PF FDC",[40],"Combination Product: QLS-111-FDC",{"label":42,"type":43,"description":44,"interventionNames":45},"Latanoprost ophthalmic solution","ACTIVE_COMPARATOR","PF latanoprost 0.005%",[46],"Drug: Latanoprost (0.005%)",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":20},"COMBINATION_PRODUCT","QLS-111-FDC","QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).",[36],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Latanoprost (0.005%)","PF latanoprost administered by TO application for 14 days QPM OU.",[42],[59],"latanoprost ophthalmic solution 0.005%, PF",[61],{"name":62,"affiliation":5,"role":63},"Barbara M Wirostko, MD","STUDY_DIRECTOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":20,"email":69},"Lisa Brandano","CONTACT","9789302103","lbrandano@qlaris.bio",{"name":71,"role":67,"phone":20,"phoneExt":20,"email":72},"Lauryl Hargreaves","lhargreaves@qlaris.bio",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":20},"Shettle Eye Research","RECRUITING","Largo","Florida","33773","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-82.78842,27.90979,{"lat":86,"lon":85},{"type":89,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100620199",false,"NCT07354516","Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension","A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension","Firecrest","Inclusion Criteria:\n\n* BCVA 1.0 logMAR or better in each eye (equivalent to 20\u002F200)\n* Diagnosis of mild to moderate OAG or OHT in at least one eye\n* IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost\n\nExclusion Criteria:\n\n* History of active ocular disease other than mild to moderate OAG\u002FOHT\n* Prior use of any topical PGA without a clinically meaningful response\n* Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study\n* Use of other topical ocular concomitant medications 30 days prior\n* History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye.\n* Central corneal thickness in either eye \\\u003C470 or \\>630 μm\n* Clinically significant systemic or psychiatric disease, chronic kidney disease, or hypertension, hypotension, or diabetes that is uncontrolled.\n* Participation in any investigational study within 30 days prior to Screening\n* Females who are pregnant, nursing, or not using birth control.","ALL","12 Years",{"count":100,"type":101},60,"ESTIMATED","INTERVENTIONAL",[104,105],"PHASE2","PHASE3","Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free \\[PF\\], fixed-dose combination \\[FDC\\] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).",[108,109],"OAG - Open-Angle Glaucoma","OHT - Ocular Hypertension",[111,112,113],"glaucoma","intraocular pressure (IOP)","eye drops","2026-03-30",{"date":116,"type":117},"2026-04-03","ACTUAL",{"date":119,"type":117},"2026-03-18",{"date":121,"type":101},"2026-07-15",{"name":5,"class":6},1]