{"id":"sodium-hyaluronate-ophthalmic-0-4","safety":{"commonSideEffects":[{"rate":null,"effect":"Transient blurred vision"},{"rate":null,"effect":"Eye irritation or discomfort"},{"rate":null,"effect":"Mild conjunctival hyperemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Sodium hyaluronate is a naturally occurring polysaccharide that mimics the viscoelastic properties of tears. When applied topically to the eye, it forms a protective hydrophilic film on the cornea and conjunctiva, providing sustained lubrication, moisture retention, and protection against further irritation. This mechanism helps restore tear film stability and reduce symptoms associated with dry eye disease.","oneSentence":"Sodium hyaluronate acts as a lubricating and hydrating agent that coats the ocular surface to relieve dry eye symptoms.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:08:32.828Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye syndrome / Keratoconjunctivitis sicca"},{"name":"Ocular surface irritation and discomfort"}]},"trialDetails":[{"nctId":"NCT04704531","phase":"PHASE2","title":"Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution as Treatment for Dry Eye Disease.","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2022-01-03","conditions":"Dry Eye","enrollment":141},{"nctId":"NCT04702776","phase":"PHASE4","title":"Study to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF With Hyabak® and Lagricel Ofteno® PF as Treatment for Dry Eye.","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2021-12-09","conditions":"Dry Eye","enrollment":182},{"nctId":"NCT06985875","phase":"PHASE3","title":"Clinical Trial for the Evaluation of Safety and Efficacy of Drop 0.4%","status":"NOT_YET_RECRUITING","sponsor":"Avizor SA","startDate":"2025-07","conditions":"Eye Dryness","enrollment":79},{"nctId":"NCT05773963","phase":"NA","title":"A Post-market Study to Evaluate the Effects of Sodium Hyaluronate Based Eye Drops in Patients Affected by Dry Eye Disease","status":"TERMINATED","sponsor":"Montefarmaco OTC SpA","startDate":"2022-02-24","conditions":"Opthalomology/Dry Eye","enrollment":80},{"nctId":"NCT06077981","phase":"NA","title":"Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections","status":"RECRUITING","sponsor":"Instituto do Cancer do Estado de São Paulo","startDate":"2023-06-19","conditions":"Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid","enrollment":30},{"nctId":"NCT06370585","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2024-05-16","conditions":"Dry Eye Disease, Ocular Surface Disease","enrollment":36},{"nctId":"NCT04704518","phase":"PHASE4","title":"Phase IV Study to Evaluate the Efficacy of Lagricel® Ofteno PF Compared to Thealoz® Duo After Photorefractive Keratectomy (PRK)","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2022-09-03","conditions":"Photorefractive Keratectomy, Corneal De-epithelialization","enrollment":88},{"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":"NCT05733741","phase":"PHASE4","title":"Preservative-free Topical Anesthetics for Post-PRK Pain","status":"COMPLETED","sponsor":"Assiut University","startDate":"2023-01-30","conditions":"Myopia","enrollment":70},{"nctId":"NCT03803748","phase":"NA","title":"A Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi®","status":"COMPLETED","sponsor":"SIFI SpA","startDate":"2019-07-17","conditions":"Dry Eye Syndromes","enrollment":96},{"nctId":"NCT05429229","phase":"PHASE2","title":"Effect of Topical Antioxidants in Dry Eye Disease and Diabetic Retinopathy","status":"UNKNOWN","sponsor":"Adolfo Daniel Rodriguez-Carrizalez","startDate":"2021-11-01","conditions":"Dry Eye Syndromes, Diabetic Retinopathy, Oxidative Stress","enrollment":78},{"nctId":"NCT04081610","phase":"PHASE1","title":"Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2019-09-09","conditions":"Dry Eye","enrollment":34},{"nctId":"NCT03521791","phase":"PHASE4","title":"Efficacy and Safety of PRO-155 on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2017-12-13","conditions":"Pterygium, Ocular Pain, Ocular Inflammation","enrollment":166},{"nctId":"NCT03223909","phase":"PHASE4","title":"Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Ultra Preservative Free (087LATAMFIV)","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2016-10-13","conditions":"Dry Eye Syndrome","enrollment":326},{"nctId":"NCT03524157","phase":"PHASE1","title":"Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2017-07-17","conditions":"Dry Eye Syndromes, Lubricant Allergy, Tear Disorder","enrollment":30},{"nctId":"NCT02980523","phase":"PHASE2","title":"Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2015-03","conditions":"Bacterial Conjunctivitis","enrollment":150},{"nctId":"NCT03480295","phase":"NA","title":"Effects of a PF Ophthalmic Solution Containing HA0.4% and TAU 0.5%","status":"COMPLETED","sponsor":"Fondazione G.B. Bietti, IRCCS","startDate":"2016-12-19","conditions":"Glaucoma","enrollment":39},{"nctId":"NCT00493662","phase":"PHASE4","title":"Cross-Over Evaluation of Two Lubricating Eye Drops","status":"COMPLETED","sponsor":"Innovative Medical","startDate":"","conditions":"Dry Eye","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":74,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Lagricel® Ofteno PF","PRO-037"],"phase":"marketed","status":"active","brandName":"Sodium Hyaluronate Ophthalmic 0.4%","genericName":"Sodium Hyaluronate Ophthalmic 0.4%","companyName":"Laboratorios Sophia S.A de C.V.","companyId":"laboratorios-sophia-s-a-de-c-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sodium hyaluronate acts as a lubricating and hydrating agent that coats the ocular surface to relieve dry eye symptoms. Used for Dry eye syndrome / Keratoconjunctivitis sicca, Ocular surface irritation and discomfort.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}