[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654285":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":36,"interventions":49,"overallOfficials":25,"centralContacts":25,"locations":58,"responsibleParty":97,"collaborators":25,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":25,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":25,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Eye Research Associates, LLC","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)","Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.","1-month post operative compared to pre-treatment",[14,17,21],{"measure":15,"description":11,"timeFrame":16},"• OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).","pre-treatment as compared to 3 months post operative.",{"measure":18,"description":19,"timeFrame":20},"Eye Dryness visual analog scale (VAS) Scores 1 month post operative","The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.","1 month post operative as compared to pre-treatment.",{"measure":22,"description":23,"timeFrame":24},"Eye Dryness visual analog scale (VAS) Scores 3 month post operative","The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.","3 month post operative as compared to pre-treatment.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Subjects will be randomized to either the Lacrifill group or the saline\u002Fstandard of care. After eligibility requirements are meant.","PREVENTION",{"masking":32,"maskingDescription":33,"whoMasked":34},"SINGLE","The Principal Investigator who is completing the assessments will be masked in order to prevent biasing the study. An unmasked coordinator not involved in the assessment portion of the study will provide information to the study participant regarding the treatment and be in charge of the randomziation.",[35],"INVESTIGATOR",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Lacrifill","EXPERIMENTAL","Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions",[42],"Drug: Lacrifill",{"label":44,"type":45,"description":46,"interventionNames":47},"Saline\u002FStandard of care","ACTIVE_COMPARATOR","Qualifying subjects will be treated with saline via the manufacturer's instructions",[48],"Drug: Saline",[50,54],{"type":51,"name":38,"description":52,"armGroupLabels":53,"otherNames":25},"DRUG","Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage",[38],{"type":51,"name":55,"description":56,"armGroupLabels":57,"otherNames":25},"Saline","Participants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease.",[44],[59,81],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Kannarr Eye Care","RECRUITING","Pittsburg","Kansas","66762","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-94.70496,37.41088,{"lat":71,"lon":70},[74,79],{"name":75,"role":76,"phone":77,"phoneExt":25,"email":78},"Shane Kannarr, OD","CONTACT","620-232-3277","skannarr@kannarreyecare.com",{"name":75,"role":80,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":82,"status":61,"city":83,"state":84,"zip":85,"country":65,"countryCode":66,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Insight Eyecare Specialties Inc","Kansas City","Missouri","64111",{"type":68,"coordinates":87},[88,89],-94.57857,39.09973,{"lat":89,"lon":88},[92,96],{"name":93,"role":76,"phone":94,"phoneExt":25,"email":95},"Crystal Remington, OD","816-531-9100","drremington@vseyecare.com",{"name":93,"role":80,"phone":25,"phoneExt":25,"email":25},{"type":98,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100654285","phase-4-evaluation-of-lacrifill-100654285",false,"NCT07796178","Evaluation of Lacrifill","Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects","Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Have the potential of 20\u002F40 visual acuity or better post-cataract surgery.\n* have cataract surgery scheduled for both eyes\n* Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye.\n* willing to discontinue contact lens throughout the study?\n* pre-treatment OSDI scores of ≤12 (asymptomatic)?\n\nExclusion Criteria:\n\n* Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)?\n* History of ocular surgery within the past 12 months (excluding cataract surgery)\n* Anticipated complications from cataract surgery in either eye?\n* History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related?\n* Used Accutane or is currently using ocular medications\u002Ftreatments outside of study treatments? Artificial tears will be allowed.\n* Physical meibomian gland treatment withing 1 month of enrollment?\n* Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.\n* Currently pregnant or breast feeding","ALL","18 Years","80 Years",{"count":110,"type":111},40,"ESTIMATED","INTERVENTIONAL",[114],"PHASE4","Dry Eye Disease is defined as \"a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.",[117,118,119,120],"Dry Eye","Ocular Surface Disease","Cataract Surgery","Eyes Dry Feeling of","2026-09-22",{"date":123,"type":124},"2026-09-25","ACTUAL",{"date":126,"type":124},"2026-09-02",{"date":128,"type":111},"2027-02-15",{"name":5,"class":6},2]