{"id":"fml-0-1-eyedrops","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or discomfort"},{"rate":null,"effect":"Transient blurred vision"},{"rate":null,"effect":"Increased intraocular pressure (with prolonged use)"},{"rate":null,"effect":"Posterior subcapsular cataract formation (with chronic use)"},{"rate":null,"effect":"Secondary ocular infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fluorometholone is a synthetic glucocorticoid that penetrates ocular tissues and binds to glucocorticoid receptors in the eye. It inhibits the release of arachidonic acid and subsequent production of prostaglandins and leukotrienes, thereby reducing inflammation, edema, and immune cell infiltration in ocular tissues.","oneSentence":"FML (fluorometholone) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:13:12.104Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis)"},{"name":"Post-operative inflammation following ocular surgery"}]},"trialDetails":[{"nctId":"NCT04149210","phase":"PHASE3","title":"FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial","status":"COMPLETED","sponsor":"Massachusetts Eye and Ear Infirmary","startDate":"2021-08-19","conditions":"Trachomatous Trichiasis (TT), Eye Diseases, Eyelid Diseases","enrollment":2410},{"nctId":"NCT06498440","phase":"PHASE4","title":"Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT","status":"NOT_YET_RECRUITING","sponsor":"St. Joseph's Healthcare Hamilton","startDate":"2024-09-01","conditions":"Open Angle Glaucoma, Ocular Hypertension, Postoperative Inflammation","enrollment":126},{"nctId":"NCT06209879","phase":"PHASE4","title":"Dual-Polymer Hydroxypropyl Guar-and Hyaluronic Acid Lubricants in Rheumatoid Arthritis","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2024-02-05","conditions":"Dry Eye Syndromes","enrollment":40},{"nctId":"NCT05131152","phase":"NA","title":"Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye","status":"UNKNOWN","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","startDate":"2021-12-01","conditions":"Dry Eye","enrollment":100},{"nctId":"NCT04376970","phase":"PHASE4","title":"Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis","status":"COMPLETED","sponsor":"Military Hospital of Tunis","startDate":"2017-04-01","conditions":"Adenoviral Keratoconjunctivitis","enrollment":51},{"nctId":"NCT02051023","phase":"PHASE3","title":"Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca)","status":"COMPLETED","sponsor":"Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA","startDate":"2014-02","conditions":"Dry Eye","enrollment":41},{"nctId":"NCT01288404","phase":"NA","title":"Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium","status":"COMPLETED","sponsor":"Ramathibodi Hospital","startDate":"2008-01","conditions":"Pterygium of the Conjunctiva and Cornea","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["0.1% fluorometholone"],"phase":"phase_3","status":"active","brandName":"FML 0.1% eyedrops","genericName":"FML 0.1% eyedrops","companyName":"Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA","companyId":"instituto-universitario-de-oftalmobiolog-a-aplicada-institute-of-applied-ophthal","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FML (fluorometholone) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators. Used for Inflammatory and allergic conditions of the anterior segment of the eye (conjunctivitis, keratitis, iritis, iridocyclitis), Post-operative inflammation following ocular surgery.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}