{"id":"prolensa-0-07-ophthalmic-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or stinging"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Corneal erosion or keratitis"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Bromfenac, the active ingredient in Prolensa, is a topical ophthalmic NSAID that works by inhibiting COX-1 and COX-2 enzymes, thereby reducing the production of prostaglandins in ocular tissues. This mechanism reduces inflammation, pain, and photophobia associated with ocular surgery and other inflammatory conditions of the eye. The 0.07% formulation is optimized for topical ocular delivery.","oneSentence":"Prolensa is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain in the eye.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:38.689Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Postoperative inflammation and pain following cataract surgery"},{"name":"Ocular itching associated with allergic conjunctivitis"}]},"trialDetails":[{"nctId":"NCT05626478","phase":"PHASE4","title":"Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery","status":"COMPLETED","sponsor":"Nicole Fram M.D.","startDate":"2023-06-01","conditions":"Corneal Edema, Corneal Defect, Anterior Chamber Inflammation","enrollment":50},{"nctId":"NCT03578276","phase":"PHASE4","title":"Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen","status":"COMPLETED","sponsor":"Carolina Eyecare Physicians, LLC","startDate":"2018-06-22","conditions":"Cataract","enrollment":35},{"nctId":"NCT03886779","phase":"PHASE4","title":"Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial","status":"COMPLETED","sponsor":"Silverstein Eye Centers","startDate":"2013-10-30","conditions":"Treatment of Ocular Inflammation Associated With Cataract Surgery","enrollment":57},{"nctId":"NCT01847638","phase":"NA","title":"Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery","status":"COMPLETED","sponsor":"Melissa Toyos","startDate":"2013-04-01","conditions":"Cataract, Retinal Edema, Inflammation","enrollment":50},{"nctId":"NCT01367249","phase":"PHASE3","title":"Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2011-05","conditions":"Pain, Inflammation, Cataract","enrollment":440}],"_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":[],"phase":"marketed","status":"active","brandName":"Prolensa 0.07% Ophthalmic Solution","genericName":"Prolensa 0.07% Ophthalmic Solution","companyName":"Nicole Fram M.D.","companyId":"nicole-fram-m-d","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Prolensa is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain in the eye. Used for Postoperative inflammation and pain following cataract surgery, Ocular itching associated with allergic conjunctivitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}