{"id":"krytantek-ofteno","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Krytantek Ofteno is developed by Laboratorios Sophia, a Mexican pharmaceutical company specializing in ophthalmologic treatments. The drug is in Phase 3 development for glaucoma management. While specific molecular targets are not publicly detailed, it is formulated as an eye drop for topical ocular administration to address elevated intraocular pressure, a key pathogenic factor in glaucoma.","oneSentence":"Krytantek Ofteno is a topical ophthalmic formulation designed to reduce intraocular pressure in glaucoma by enhancing aqueous humor outflow or reducing aqueous humor production.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:17:56.893Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Glaucoma (intraocular pressure reduction)"}]},"trialDetails":[{"nctId":"NCT03193333","phase":"PHASE3","title":"PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)","status":"TERMINATED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2017-11-06","conditions":"Primary Open-angle Glaucoma","enrollment":51},{"nctId":"NCT04702789","phase":"PHASE4","title":"Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.","status":"TERMINATED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2021-10-19","conditions":"Glaucoma, Open-Angle, Ocular Hypertension","enrollment":28},{"nctId":"NCT03966365","phase":"PHASE1","title":"Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2019-05-02","conditions":"Glaucoma","enrollment":24},{"nctId":"NCT03257813","phase":"PHASE3","title":"Non-inferiority of PRO-122 Ophthalmic Solution vs KRYTANTEK Ofteno® in Glaucoma or Ocular Hypertension (CONFORTK)","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2016-04-01","conditions":"Primary Open Angle Glaucoma, Ocular Hypertension","enrollment":60},{"nctId":"NCT01062971","phase":"PHASE2","title":"Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2006-02","conditions":"Primary Open Angle Glaucoma, Ocular Hypertension","enrollment":124}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["timolol 0.5%","brimonidine 0.2%","dorzolamide 2%","timolol, dorzolamide, brimonidine"],"phase":"phase_3","status":"active","brandName":"Krytantek Ofteno®","genericName":"Krytantek Ofteno®","companyName":"Laboratorios Sophia S.A de C.V.","companyId":"laboratorios-sophia-s-a-de-c-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Krytantek Ofteno is a topical ophthalmic formulation designed to reduce intraocular pressure in glaucoma by enhancing aqueous humor outflow or reducing aqueous humor production. Used for Glaucoma (intraocular pressure reduction).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}