{"id":"rebamipide-2-ophthalmic-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Eye irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Blurred vision"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Rebamipide is a mucoprotective agent that enhances the production of mucin by goblet cells in the conjunctiva, thereby improving tear film stability and ocular surface protection. It also exhibits anti-inflammatory properties by reducing cytokine production and protecting corneal and conjunctival epithelial cells from damage. These mechanisms make it effective for treating dry eye disease and other ocular surface disorders.","oneSentence":"Rebamipide promotes ocular surface healing and reduces inflammation by stimulating mucin secretion and protecting epithelial cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:04:06.433Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease"},{"name":"Ocular surface disorder"}]},"trialDetails":[{"nctId":"NCT07397949","phase":"PHASE4","title":"Rebamipide Versus Diquafosol for Perioperative Dry Eye in Cataract Surgery","status":"NOT_YET_RECRUITING","sponsor":"Samsung Medical Center","startDate":"2026-03","conditions":"Dry Eye Disease (DED), Cataract","enrollment":60},{"nctId":"NCT07397936","phase":"PHASE4","title":"Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery","status":"COMPLETED","sponsor":"Samsung Medical Center","startDate":"2024-08-01","conditions":"Dry Eye Disease (DED), Cataract","enrollment":55},{"nctId":"NCT01471093","phase":"PHASE1","title":"Safety Study of OPC-12759 Ophthalmic Solution","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2011-11","conditions":"Dry Eye Syndromes","enrollment":100},{"nctId":"NCT01493180","phase":"PHASE2","title":"Exploratory Study of OPC-12759 Ophthalmic Suspension","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2011-12","conditions":"Keratoconjunctival Epithelial Disorder","enrollment":102},{"nctId":"NCT00885079","phase":"PHASE3","title":"Confirmatory Study of OPC-12759 Ophthalmic Suspension","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2009-05","conditions":"Dry Eye Syndromes","enrollment":188},{"nctId":"NCT01057147","phase":"PHASE2","title":"Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea","status":"COMPLETED","sponsor":"Kubota Vision Inc.","startDate":"2010-02","conditions":"Keratoconjunctivitis Sicca, Dry Eye","enrollment":116},{"nctId":"NCT01027013","phase":"PHASE2","title":"Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye","status":"COMPLETED","sponsor":"Kubota Vision Inc.","startDate":"2009-12","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":220},{"nctId":"NCT00201981","phase":"PHASE3","title":"Study of Rebamipide Eye Drops to Treat Dry Eye","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2004-05","conditions":"Keratoconjunctivitis Sicca","enrollment":740}],"_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":"Rebamipide 2% ophthalmic solution","genericName":"Rebamipide 2% ophthalmic solution","companyName":"Samsung Medical Center","companyId":"samsung-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Rebamipide promotes ocular surface healing and reduces inflammation by stimulating mucin secretion and protecting epithelial cells. Used for Dry eye disease, Ocular surface disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}