{"id":"kpi-121-0-25","safety":{"commonSideEffects":[{"rate":null,"effect":"Instillation site irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye discomfort"}]},"_chembl":{"chemblId":"CHEMBL2766016","moleculeType":"Small molecule","molecularWeight":"831.25"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KPI-121 is a 0.25% ophthalmic suspension designed to deliver anti-inflammatory and lubricating agents directly to the ocular surface with enhanced residence time. The formulation uses Kala's proprietary mucoadhesive technology to maintain prolonged contact with the eye, improving therapeutic efficacy for dry eye disease and related inflammatory conditions.","oneSentence":"KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:55.726Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease"},{"name":"Ocular surface inflammation"}]},"trialDetails":[{"nctId":"NCT03616899","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With DED","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2018-07-10","conditions":"Kerato Conjunctivitis Sicca","enrollment":901},{"nctId":"NCT02813265","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2016-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":918},{"nctId":"NCT02163824","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-05","conditions":"Ocular Infections, Irritations and Inflammations","enrollment":380},{"nctId":"NCT02218489","phase":"PHASE2","title":"Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-07","conditions":"Blepharitis","enrollment":206},{"nctId":"NCT02188160","phase":"PHASE2","title":"Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":150},{"nctId":"NCT02819284","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2016-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":909},{"nctId":"NCT02245516","phase":"NA","title":"Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-07","conditions":"Retinal Vein Occlusion, Diabetic Macular Edema","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["KPI-121 0.25% Ophthalmic Suspension","Loteprednol etabonate 0.25%"],"phase":"phase_3","status":"active","brandName":"KPI-121 0.25%","genericName":"KPI-121 0.25%","companyName":"Kala Pharmaceuticals, Inc.","companyId":"kala-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system. Used for Dry eye disease, Ocular surface inflammation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}