{"id":"fluorometholone-fml","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation or discomfort"},{"rate":null,"effect":"Transient blurred vision"},{"rate":null,"effect":"Elevated 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 reduces inflammation by inhibiting the release of inflammatory mediators and suppressing immune cell activity in ocular tissues. It is a fluorinated corticosteroid with moderate potency, designed for topical ophthalmic use to minimize systemic absorption while maintaining local anti-inflammatory efficacy.","oneSentence":"Fluorometholone is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:31:02.081Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammatory and allergic conditions of the eye (conjunctivitis, keratitis, iritis)"},{"name":"Post-operative ocular inflammation"},{"name":"Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe"}]},"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":"NCT07308938","phase":"PHASE2","title":"Fluorometholone Study","status":"NOT_YET_RECRUITING","sponsor":"Vishal Jhanji","startDate":"2026-03-31","conditions":"Keratitis Bacterial, Corneal Ulcer (Diagnosis)","enrollment":174},{"nctId":"NCT05716945","phase":"PHASE4","title":"The OPTIMISE Study","status":"RECRUITING","sponsor":"Maastricht University Medical Center","startDate":"2024-07-29","conditions":"Pseudophakic Bullous Keratopathy, Fuchs' Endothelial Dystrophy, Intraocular Pressure","enrollment":342},{"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":"NCT04839549","phase":"PHASE4","title":"Efficacy and Safety of Dextenza Compared to Topical Fluorometholone in Patients With Ocular Rosacea","status":"WITHDRAWN","sponsor":"Eye Associates of Central Texas","startDate":"2020-06-06","conditions":"Ocular Rosacea","enrollment":""},{"nctId":"NCT02030990","phase":"PHASE2, PHASE3","title":"The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements","status":"UNKNOWN","sponsor":"United States Naval Medical Center, San Diego","startDate":"2014-08","conditions":"Corneal Opacity","enrollment":300},{"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":"NCT04117698","phase":"PHASE3","title":"Multicenter, Randomized Study Evaluating the Value of Antitubercular Treatment During Recurent Anterior Uveitis (URBA)","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2019-11-01","conditions":"Uveitis, Anterior","enrollment":116},{"nctId":"NCT01189864","phase":"","title":"Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas","status":"TERMINATED","sponsor":"Cxlusa","startDate":"2010-02-01","conditions":"Keratoconus, Ectasia, Degeneration","enrollment":3493},{"nctId":"NCT01024322","phase":"","title":"Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas","status":"TERMINATED","sponsor":"Cxlusa","startDate":"2009-10-01","conditions":"Keratoconus, Ectasia, Degeneration","enrollment":1189},{"nctId":"NCT01097447","phase":"","title":"Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)","status":"TERMINATED","sponsor":"Cxlusa","startDate":"2009-12-01","conditions":"Keratoconus, Ectasia, Degeneration","enrollment":2619},{"nctId":"NCT02974387","phase":"PHASE4","title":"Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study","status":"UNKNOWN","sponsor":"Dr Salouti Eye Research Center","startDate":"2017-04","conditions":"Must be PRK Candidate","enrollment":200},{"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":"NCT02218827","phase":"NA","title":"Topical Steroid Treatment For Dry Eye","status":"UNKNOWN","sponsor":"Meir Medical Center","startDate":"2014-09","conditions":"Dry Eye","enrollment":30},{"nctId":"NCT00824811","phase":"PHASE2","title":"Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2009-06","conditions":"Epiphora","enrollment":""},{"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},{"nctId":"NCT00707421","phase":"PHASE3","title":"Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes","status":"COMPLETED","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"2005-07","conditions":"Glaucoma, Trabeculectomy, Fibrosis","enrollment":62}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"ATRIAL FLUTTER"},{"count":1,"reaction":"CHEST PAIN"},{"count":1,"reaction":"THROMBOSIS"}],"_approvalHistory":[],"publicationCount":63,"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":"Fluorometholone(FML)","genericName":"Fluorometholone(FML)","companyName":"Dr Salouti Eye Research Center","companyId":"dr-salouti-eye-research-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fluorometholone is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors. Used for Inflammatory and allergic conditions of the eye (conjunctivitis, keratitis, iritis), Post-operative ocular inflammation, Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}