{"id":"loteprednol-etabonate-0-5","safety":{"commonSideEffects":[{"rate":null,"effect":"Elevated intraocular pressure"},{"rate":null,"effect":"Ocular irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Posterior subcapsular cataract formation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Loteprednol etabonate is a soft corticosteroid designed to minimize systemic absorption and reduce side effects compared to traditional corticosteroids. It works by binding to intracellular glucocorticoid receptors and modulating gene expression to reduce production of inflammatory mediators, cytokines, and immune cell activation. The ester structure allows for rapid metabolism, reducing systemic exposure while maintaining local anti-inflammatory efficacy.","oneSentence":"Loteprednol etabonate is a corticosteroid that suppresses inflammatory and immune responses by binding to glucocorticoid receptors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:53:13.790Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammation and pain following ocular surgery"},{"name":"Seasonal allergic conjunctivitis"},{"name":"Uveitis"}]},"trialDetails":[{"nctId":"NCT02120079","phase":"PHASE4","title":"The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED","status":"COMPLETED","sponsor":"Tufts Medical Center","startDate":"2014-02","conditions":"Dry Eye Disease","enrollment":37},{"nctId":"NCT04555694","phase":"PHASE4","title":"Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax","status":"COMPLETED","sponsor":"Thomas Chester, OD","startDate":"2020-10-01","conditions":"Dry Eye","enrollment":30},{"nctId":"NCT05353101","phase":"PHASE1","title":"Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Nanchang University","startDate":"2020-07-01","conditions":"Vernal Keratoconjunctivitis, Cyclosporine 0.05% Eye Drops","enrollment":48},{"nctId":"NCT04911361","phase":"PHASE4","title":"The DEPOT Study (Dry Eye Prescription Options for Therapy)","status":"COMPLETED","sponsor":"Research Insight LLC","startDate":"2021-08-10","conditions":"Dry Eye","enrollment":50},{"nctId":"NCT03123614","phase":"PHASE4","title":"Loteprednol vs. Prednisolone and Fluorometholone","status":"COMPLETED","sponsor":"University of Utah","startDate":"2014-09-19","conditions":"Intraocular Pressure, Corneal Opacity","enrollment":131},{"nctId":"NCT01437982","phase":"PHASE4","title":"A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2010-08-05","conditions":"Conjunctivitis, Seasonal Allergic, Conjunctivitis, Giant Papillary, Inflammation","enrollment":140},{"nctId":"NCT01817582","phase":"PHASE2","title":"Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2013-05-17","conditions":"Keratoconjunctivitis Sicca","enrollment":102},{"nctId":"NCT01475643","phase":"PHASE3","title":"Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2013-06","conditions":"Cataract","enrollment":107},{"nctId":"NCT01344226","phase":"","title":"Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery","status":"COMPLETED","sponsor":"Toyos Clinic","startDate":"2011-04","conditions":"Pseudophakia, Inflammation","enrollment":49},{"nctId":"NCT03464435","phase":"PHASE4","title":"A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis","status":"COMPLETED","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","startDate":"2016-11-01","conditions":"Vernal Keratoconjunctivitis","enrollment":20},{"nctId":"NCT01384266","phase":"","title":"A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery","status":"COMPLETED","sponsor":"Associated Eye Care, Minnesota","startDate":"2010-05","conditions":"Intraocular Inflammation","enrollment":90},{"nctId":"NCT02825186","phase":"NA","title":"Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery","status":"UNKNOWN","sponsor":"Tel-Aviv Sourasky Medical Center","startDate":"2016-07","conditions":"Ophthalmology","enrollment":100},{"nctId":"NCT01695668","phase":"NA","title":"Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%","status":"COMPLETED","sponsor":"University of Michigan","startDate":"2011-08","conditions":"Dry Eyes","enrollment":75},{"nctId":"NCT01853696","phase":"PHASE4","title":"Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty","status":"COMPLETED","sponsor":"Cornea Research Foundation of America","startDate":"2013-03","conditions":"Fuchs' Dystrophy, Corneal Edema","enrollment":167},{"nctId":"NCT00699153","phase":"PHASE3","title":"Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2008-06","conditions":"Ocular Inflammation","enrollment":400},{"nctId":"NCT00645671","phase":"PHASE3","title":"Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2008-03","conditions":"Ocular Inflammation","enrollment":400},{"nctId":"NCT02028312","phase":"PHASE4","title":"A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®","status":"WITHDRAWN","sponsor":"Edward Holland, MD","startDate":"2014-01","conditions":"Dry Eye Disease","enrollment":""},{"nctId":"NCT01724892","phase":"PHASE4","title":"Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing","status":"COMPLETED","sponsor":"Khon Kaen University","startDate":"2012-11","conditions":"Epithelial Defect After Phototherapeutic Keratectomy","enrollment":32},{"nctId":"NCT01692652","phase":"NA","title":"Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2012-08","conditions":"Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)","enrollment":98},{"nctId":"NCT01736527","phase":"PHASE1","title":"Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2013-01","conditions":"Pharmacokinetics","enrollment":12},{"nctId":"NCT01193504","phase":"PHASE4","title":"Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification","status":"UNKNOWN","sponsor":"Innovative Medical","startDate":"2010-09","conditions":"Pseudophakia, Cataract Surgery","enrollment":100},{"nctId":"NCT01060072","phase":"PHASE3","title":"Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2010-02","conditions":"Inflammation, Pain","enrollment":407},{"nctId":"NCT00447577","phase":"PHASE4","title":"Zylet vs TobraDex in Blepharokeratoconjunctivitis","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2007-01","conditions":"Blepharokeratoconjunctivitis","enrollment":276},{"nctId":"NCT00532961","phase":"PHASE4","title":"Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2005-02","conditions":"Inflammation","enrollment":310},{"nctId":"NCT00420628","phase":"PHASE4","title":"Pediatric Zylet Safety and Efficacy Study","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2006-11","conditions":"Chalazion, Hordeolum","enrollment":108},{"nctId":"NCT00834171","phase":"","title":"A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin","status":"COMPLETED","sponsor":"Allergan","startDate":"2009-01","conditions":"Ocular Hypertension","enrollment":50},{"nctId":"NCT00560638","phase":"PHASE2","title":"Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2005-11","conditions":"Dry Eye","enrollment":119},{"nctId":"NCT00781300","phase":"PHASE4","title":"Intraocular Pressure With Loteprednol and Dexamethasone","status":"COMPLETED","sponsor":"Federal University of São Paulo","startDate":"2006-03","conditions":"Glaucoma, Open-Angle, Ocular Hypertension","enrollment":35}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":55,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Loteprol","Lotemax"],"phase":"marketed","status":"active","brandName":"Loteprednol Etabonate 0.5%","genericName":"Loteprednol Etabonate 0.5%","companyName":"Federal University of São Paulo","companyId":"federal-university-of-s-o-paulo","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Loteprednol etabonate is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors. Used for Inflammation and pain following ocular surgery, Seasonal allergic conjunctivitis, Uveitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}