{"id":"ketorolac-tromethamine-0-4","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or stinging"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Corneal erosion or ulceration (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As an NSAID, ketorolac blocks COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. In ophthalmic formulation (0.4% solution), it reduces ocular inflammation and pain by local inhibition of these pathways. The tromethamine salt form enhances solubility and bioavailability for topical ocular delivery.","oneSentence":"Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:51:09.750Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Postoperative ocular inflammation and pain following cataract surgery"},{"name":"Ocular itching associated with seasonal allergic conjunctivitis"},{"name":"Corneal refractive surgery pain and inflammation"}]},"trialDetails":[{"nctId":"NCT07276906","phase":"PHASE4","title":"Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy","status":"NOT_YET_RECRUITING","sponsor":"University of South Alabama","startDate":"2026-01","conditions":"Postoperative Pain","enrollment":300},{"nctId":"NCT06681688","phase":"PHASE1, PHASE2","title":"Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC","status":"RECRUITING","sponsor":"Inder Paul Singh, M.D.","startDate":"2024-07-10","conditions":"Cataract","enrollment":94},{"nctId":"NCT00634972","phase":"PHASE4","title":"Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity","status":"TERMINATED","sponsor":"University of South Alabama","startDate":"2005-11","conditions":"Retinopathy of Prematurity, Retinal Detachment, Blindness","enrollment":83},{"nctId":"NCT00478036","phase":"NA","title":"Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells","status":"TERMINATED","sponsor":"University of Colorado, Denver","startDate":"2007-05","conditions":"Open Angle Glaucoma","enrollment":31},{"nctId":"NCT00410267","phase":"","title":"Trial Comparing Ketorolac Tromethamine 0.4% & Prednisolone Acetate 1% in Reducing Post-SLT Anterior Chamber Flare & Cells","status":"TERMINATED","sponsor":"University of Pittsburgh","startDate":"2006-02","conditions":"Postoperative Complications, Inflammation, Glaucoma, Open-Angle","enrollment":1},{"nctId":"NCT01542190","phase":"PHASE4","title":"Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery","status":"COMPLETED","sponsor":"University of Campinas, Brazil","startDate":"2011-02","conditions":"Cystoid Macular Edema Following Cataract Surgery, Bilateral","enrollment":80},{"nctId":"NCT02084576","phase":"PHASE4","title":"Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification","status":"COMPLETED","sponsor":"Hospital Oftalmologico de Brasilia","startDate":"2013-08","conditions":"Cystoid Macular Edema, Cataract","enrollment":40},{"nctId":"NCT00332774","phase":"PHASE3","title":"Nevanac 3-Month Safety Study With QID Dosing","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2006-02","conditions":"Cataract","enrollment":149},{"nctId":"NCT00865540","phase":"PHASE4","title":"Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies","status":"UNKNOWN","sponsor":"Clinica Oftamologica Zona Sul","startDate":"2009-03","conditions":"Cataract","enrollment":30},{"nctId":"NCT01279551","phase":"PHASE2, PHASE3","title":"Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy","status":"COMPLETED","sponsor":"University of Roma La Sapienza","startDate":"2004-01","conditions":"Pain After Stapled Haemorrhoidopexy","enrollment":40},{"nctId":"NCT00469690","phase":"PHASE4","title":"Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients: Trough Drug Effects","status":"COMPLETED","sponsor":"Innovative Medical","startDate":"2007-05","conditions":"Cataract","enrollment":58}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":23,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"ketorolac tromethamine 0.4%","genericName":"ketorolac tromethamine 0.4%","companyName":"Clinica Oftamologica Zona Sul","companyId":"clinica-oftamologica-zona-sul","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Postoperative ocular inflammation and pain following cataract surgery, Ocular itching associated with seasonal allergic conjunctivitis, Corneal refractive surgery pain and inflammation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}