{"id":"levofloxacin-ophthalmic","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Eye irritation","drugRate":"10%","severity":"Mild"},{"effect":"Eye itching","drugRate":"8%","severity":"Mild"},{"effect":"Eye redness","drugRate":"5%","severity":"Mild"}],"contraindications":["Hypersensitivity to levofloxacin or any component of the formulation"],"specialPopulations":{"Geriatric":"No overall differences in safety or effectiveness between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.","Lactation":"It is not known whether this drug is excreted in human milk. Caution should be exercised when administered to a nursing woman.","Pediatric":"Safety and effectiveness in pediatric patients have not been established.","Pregnancy":"Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans."}},"trials":[],"_chembl":null,"aliases":["Cravit 0.5%","Cravit(R)","Cravit 1.5%"],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.9840/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$714","description":"LEVOFLOXACIN 25 MG/ML SOLUTION","retrievedDate":"2026-04-07"}],"offLabel":[],"timeline":[{"date":"2023-01-01","type":"Commercial","milestone":"Initial market release","regulator":"Not applicable"}],"_dailymed":null,"aiSummary":"Levofloxacin ophthalmic is an antibiotic solution used to treat bacterial conjunctivitis. It is manufactured by the National University of Malaysia and does not have an FDA label. The drug works by inhibiting bacterial DNA gyrase, preventing bacterial replication. Common side effects include eye irritation, itching, and redness. It is generally well-tolerated but has specific contraindications and warnings for certain patient populations.","ecosystem":[],"mechanism":{"target":"DNA gyrase","novelty":"Levofloxacin is a broad-spectrum antibiotic with activity against both Gram-positive and Gram-negative bacteria.","modality":"Topical ophthalmic solution","drugClass":"Fluoroquinolone","explanation":"It interferes with the bacterial DNA replication process by binding to and inhibiting the activity of DNA gyrase, an essential enzyme for bacterial DNA replication.","oneSentence":"Levofloxacin ophthalmic is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase, leading to bacterial cell death.","technicalDetail":"Levofloxacin binds to the A subunit of DNA gyrase, stabilizing the cleaved complex and preventing the re-ligation of the DNA strands, which leads to double-strand breaks and ultimately bacterial cell death."},"_scrapedAt":"2026-03-27T23:52:02.755Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"Patients with bacterial conjunctivitis","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":["Bacterial conjunctivitis"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04371445","phase":"PHASE4","title":"Dextenza in the Post-op Management of Vitreoretinal Surgeries","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2020-06-01","conditions":"Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain","enrollment":30},{"nctId":"NCT05816070","phase":"PHASE2","title":"Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis","status":"COMPLETED","sponsor":"IVIEW Therapeutics Inc.","startDate":"2023-01-05","conditions":"Acute Bacterial Conjunctivitis","enrollment":129},{"nctId":"NCT03933631","phase":"PHASE3","title":"Pilocarpine Use After Kahook Goniotomy","status":"RECRUITING","sponsor":"Montefiore Medical Center","startDate":"2019-05-01","conditions":"Glaucoma","enrollment":142},{"nctId":"NCT06616922","phase":"PHASE2","title":"Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults","status":"COMPLETED","sponsor":"NTC srl","startDate":"2021-11-05","conditions":"Conjunctivitis, Bacterial","enrollment":252},{"nctId":"NCT02528123","phase":"NA","title":"VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia","status":"COMPLETED","sponsor":"London Vision Clinic","startDate":"2016-04","conditions":"Myopia, Refractive Errors","enrollment":114},{"nctId":"NCT05441930","phase":"PHASE1","title":"A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery","status":"WITHDRAWN","sponsor":"PolyActiva Pty Ltd","startDate":"2023-06-23","conditions":"Cataract","enrollment":""},{"nctId":"NCT04200651","phase":"PHASE4","title":"Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery","status":"TERMINATED","sponsor":"The New York Eye Surgery Center","startDate":"2020-01-13","conditions":"Glaucoma, Cataract","enrollment":25},{"nctId":"NCT06221345","phase":"PHASE4","title":"Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2021-12-07","conditions":"Dry Eye Disease, Cataract","enrollment":70},{"nctId":"NCT05741632","phase":"PHASE1","title":"Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery","status":"COMPLETED","sponsor":"Indonesia University","startDate":"2023-02-01","conditions":"Cataract","enrollment":68},{"nctId":"NCT05614622","phase":"NA","title":"Mydriatic Drops After Combined Surgery","status":"COMPLETED","sponsor":"Rabin Medical Center","startDate":"2020-11-10","conditions":"Posterior Synechiae of Iris","enrollment":60},{"nctId":"NCT04598282","phase":"NA","title":"Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis","status":"WITHDRAWN","sponsor":"Oregon Health and Science University","startDate":"2021-01-21","conditions":"Herpes Simplex Dendritic Keratitis","enrollment":""},{"nctId":"NCT05213156","phase":"PHASE4","title":"Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease","status":"COMPLETED","sponsor":"University Hospital of Patras","startDate":"2019-09-24","conditions":"Dry Eye Disease","enrollment":91},{"nctId":"NCT04005079","phase":"PHASE3","title":"Pilocarpine After Combined Cataract/Trabectome Surgery","status":"WITHDRAWN","sponsor":"Montefiore Medical Center","startDate":"2019-06-05","conditions":"Open Angle Glaucoma, Ocular Hypertension","enrollment":""},{"nctId":"NCT04682288","phase":"PHASE1","title":"Levofloxacin Ocular Implant for Ocular Surgery","status":"COMPLETED","sponsor":"PolyActiva Pty Ltd","startDate":"2021-01-04","conditions":"Cataract","enrollment":5},{"nctId":"NCT02373137","phase":"PHASE4","title":"Descemet Endothelial Thickness Comparison Trial","status":"UNKNOWN","sponsor":"Oregon Health and Science University","startDate":"2015-01-22","conditions":"Keratoplasty, Grafting, Corneal, Transplantation, Corneal","enrollment":38},{"nctId":"NCT02717871","phase":"PHASE3","title":"Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis","status":"COMPLETED","sponsor":"University Hospital, Geneva","startDate":"2016-03","conditions":"Keratitis; Infectious Disease (Manifestation)","enrollment":35},{"nctId":"NCT04212429","phase":"PHASE1, PHASE2","title":"The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%","status":"UNKNOWN","sponsor":"National University of Malaysia","startDate":"2019-09-23","conditions":"Endophthalmitis Postoperative","enrollment":128},{"nctId":"NCT04214821","phase":"PHASE1, PHASE2","title":"The Pharmacokinetics of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%","status":"UNKNOWN","sponsor":"National University of Malaysia","startDate":"2019-09-23","conditions":"Endophthalmitis","enrollment":128},{"nctId":"NCT04212078","phase":"PHASE1, PHASE2","title":"Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime","status":"UNKNOWN","sponsor":"National University of Malaysia","startDate":"2019-07-29","conditions":"Endophthalmitis Postoperative","enrollment":138},{"nctId":"NCT03739528","phase":"PHASE3","title":"Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery","status":"COMPLETED","sponsor":"NTC srl","startDate":"2018-09-03","conditions":"Cataract","enrollment":808},{"nctId":"NCT03740659","phase":"PHASE2","title":"Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery","status":"COMPLETED","sponsor":"NTC srl","startDate":"2018-09-04","conditions":"Cataract","enrollment":125},{"nctId":"NCT04403334","phase":"PHASE4","title":"Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin","status":"COMPLETED","sponsor":"Peregrine Eye and Laser Institute","startDate":"2018-01-02","conditions":"Cataract Senile, Endophthalmitis, Antibiotic Side Effect","enrollment":114},{"nctId":"NCT04213313","phase":"","title":"Association Between SNP of SP-D and Susceptibility and Prognosis of Infectious Keratitis","status":"COMPLETED","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2016-10-01","conditions":"Infectious Keratitis","enrollment":145},{"nctId":"NCT03519516","phase":"PHASE1","title":"Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2018-01-25","conditions":"Conjunctivitis, Conjunctivitis, Bacterial","enrollment":30},{"nctId":"NCT03042871","phase":"PHASE4","title":"Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization","status":"COMPLETED","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","startDate":"2015-04","conditions":"Choroidal Neovascularization","enrollment":54},{"nctId":"NCT03631108","phase":"","title":"Feasibility Study and Preliminary Application Study on Iris OCTA","status":"UNKNOWN","sponsor":"Shanghai Eye Disease Prevention and Treatment Center","startDate":"2018-10","conditions":"Conjunctivitis, Glaucoma, Myopia","enrollment":4000},{"nctId":"NCT02573610","phase":"PHASE3","title":"Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery","status":"COMPLETED","sponsor":"Santen Pharmaceutical Co., Ltd.","startDate":"2015-09-21","conditions":"Cataract Surgery","enrollment":576},{"nctId":"NCT02540785","phase":"NA","title":"Early Changes Between Lenticule Extraction and Small-Incision Lenticule Extraction","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2014-04","conditions":"Myopia, Astigmatism","enrollment":41},{"nctId":"NCT02551796","phase":"NA","title":"Early Changes Among FLEx, LASIK and FS-LASIK","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2015-09","conditions":"Myopia, Astigmatism","enrollment":75},{"nctId":"NCT01573910","phase":"PHASE3","title":"An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2012-05","conditions":"Bacterial Conjunctivitis","enrollment":985},{"nctId":"NCT02148016","phase":"PHASE1, PHASE2","title":"Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation","status":"UNKNOWN","sponsor":"Sun Yat-sen University","startDate":"2012-12","conditions":"Corneal Disease, Pterygium, Myopia","enrollment":30},{"nctId":"NCT02028754","phase":"PHASE4","title":"A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms","status":"COMPLETED","sponsor":"Allergan","startDate":"2011-07","conditions":"Dry Eye Syndromes, Cataract","enrollment":180},{"nctId":"NCT00392275","phase":"PHASE4","title":"Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs","status":"COMPLETED","sponsor":"Indiana University School of Medicine","startDate":"2002-11","conditions":"Cataract","enrollment":48},{"nctId":"NCT01761071","phase":"PHASE3","title":"Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2012-01","conditions":"Myopes Who Have Undergone PRK.","enrollment":94},{"nctId":"NCT00840580","phase":"PHASE4","title":"Effect on Wound Healing of Vigamox Versus Cravit","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2009-01","conditions":"Cataract Extraction","enrollment":79},{"nctId":"NCT00764582","phase":"PHASE4","title":"Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery","status":"TERMINATED","sponsor":"Santen Inc.","startDate":"2008-09","conditions":"Corneal Transplantation","enrollment":60},{"nctId":"NCT00703313","phase":"PHASE4","title":"Ocular Availability in Human Tears After Topical Administration of 1.5% Levofloxacin Compared to Active Comparators","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2008-05","conditions":"Healthy","enrollment":72},{"nctId":"NCT00630019","phase":"PHASE4","title":"Ocular Tissue Levels of 1.5% Levofloxacin Ophthalmic Solution Compared to an Active Comparator","status":"COMPLETED","sponsor":"Santen Inc.","startDate":"2008-02","conditions":"Cataract","enrollment":96},{"nctId":"NCT00565123","phase":"PHASE2, PHASE3","title":"Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis","status":"COMPLETED","sponsor":"Laser Microsurgery Centre, Poland","startDate":"2004-09","conditions":"Bacterial Conjunctivitis","enrollment":119},{"nctId":"NCT00491049","phase":"PHASE4","title":"Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery","status":"COMPLETED","sponsor":"Ludwig-Maximilians - University of Munich","startDate":"2004-09","conditions":"Conjunctival Bacterial Flora","enrollment":140}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"CANDIDIASIS"},{"count":2,"reaction":"MALAISE"},{"count":2,"reaction":"PYREXIA"},{"count":2,"reaction":"ULCERATIVE KERATITIS"},{"count":1,"reaction":"AGEUSIA"},{"count":1,"reaction":"ALOPECIA"},{"count":1,"reaction":"ANAPHYLACTIC SHOCK"},{"count":1,"reaction":"ANGIONEUROTIC OEDEMA"},{"count":1,"reaction":"ANTI-SS-A ANTIBODY POSITIVE"},{"count":1,"reaction":"ASPERGILLOSIS"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":16,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Levofloxacin Ophthalmic","genericName":"Levofloxacin Ophthalmic","companyName":"National University of Malaysia","companyId":"national-university-of-malaysia","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}