{"id":"systane-ultra-preservative-free","safety":{"commonSideEffects":[{"rate":null,"effect":"Transient blurred vision"},{"rate":null,"effect":"Eye irritation or stinging"},{"rate":null,"effect":"Conjunctival hyperemia"}]},"_chembl":null,"_dailymed":{"setId":"751fb85f-6683-4b0a-a650-324d4a74c5de","title":"SYSTANE ULTRA PRESERVATIVE FREE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This ophthalmic lubricant contains a proprietary blend of demulcents and emollients that mimic natural tear composition, providing sustained hydration and protection to the cornea and conjunctiva. The preservative-free formulation reduces irritation from chemical preservatives, making it suitable for frequent use in patients with dry eye disease or those sensitive to preserved eye drops.","oneSentence":"Systane Ultra Preservative Free is an artificial tear solution that lubricates and protects the ocular surface to relieve dry eye symptoms.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:38:22.703Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease / Keratoconjunctivitis sicca"},{"name":"Ocular surface irritation and discomfort"}]},"trialDetails":[{"nctId":"NCT07243275","phase":"PHASE4","title":"SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease","status":"RECRUITING","sponsor":"Indiana University","startDate":"2026-02-18","conditions":"Dry Eye Disease (DED)","enrollment":260},{"nctId":"NCT06966349","phase":"PHASE4","title":"Quantifying Ocular Surface Aberrations After Tear Film Interventions","status":"RECRUITING","sponsor":"University of Waterloo","startDate":"2025-06-10","conditions":"Tear Film Characteristics","enrollment":12},{"nctId":"NCT05902364","phase":"NA","title":"Systane® Ultra Preservative Free Lubricant Eye Drops","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2023-10-28","conditions":"Dry Eye","enrollment":69},{"nctId":"NCT06571656","phase":"NA","title":"Evaluation of the Safety and Tolerability of Ocular Lubricants","status":"TERMINATED","sponsor":"Alcon Research","startDate":"2025-04-02","conditions":"Dry Eye Disease","enrollment":73},{"nctId":"NCT05932225","phase":"NA","title":"Systane® Complete Preservative Free Lubricant Eye Drops","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2023-08-18","conditions":"Dry Eye","enrollment":71},{"nctId":"NCT05705518","phase":"PHASE4","title":"Artificial Tears, Tear Lipids and Tear Film Dynamics","status":"COMPLETED","sponsor":"University of California, Berkeley","startDate":"2023-01-30","conditions":"Dry Eye","enrollment":81},{"nctId":"NCT05932238","phase":"NA","title":"Systane® Hydration PF and Systane® Hydration Preserved","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2023-10-06","conditions":"Dry Eye","enrollment":137},{"nctId":"NCT06221345","phase":"PHASE4","title":"Hyaluronic Acid-containing Artificial Tears in Post-cataract Surgery Dry Eye Disease","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2021-12-07","conditions":"Dry Eye Disease, Cataract","enrollment":70},{"nctId":"NCT05660681","phase":"NA","title":"Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops","status":"COMPLETED","sponsor":"Calm Water Therapeutics LLC","startDate":"2022-12-12","conditions":"Dry Eye Disease","enrollment":34},{"nctId":"NCT05292755","phase":"PHASE4","title":"Effects of Carboxymethylcellulose Artificial Tears on the Eye Microbiome","status":"COMPLETED","sponsor":"University of Florida","startDate":"2022-04-22","conditions":"Dry Eye Syndromes","enrollment":80},{"nctId":"NCT04837807","phase":"PHASE4","title":"Digital Device Users Who Are Treated With Systane Hydration PF","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2021-08-18","conditions":"Dry Eye","enrollment":30},{"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":"NCT02470429","phase":"NA","title":"Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2015-07-17","conditions":"Dry Eye","enrollment":114},{"nctId":"NCT00812721","phase":"NA","title":"Tears Substitutions and Their Effects on Higher Order Aberrometery","status":"WITHDRAWN","sponsor":"Gina Rogers","startDate":"2009-01","conditions":"Dry Eye Syndrome","enrollment":""},{"nctId":"NCT01967147","phase":"NA","title":"Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2014-02","conditions":"Dry Eye","enrollment":279},{"nctId":"NCT01863368","phase":"NA","title":"Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2013-09","conditions":"Dry Eye Syndrome","enrollment":105},{"nctId":"NCT01193231","phase":"","title":"A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing","status":"COMPLETED","sponsor":"Durrie Vision","startDate":"2010-08","conditions":"Must be PRK Candidate","enrollment":10}],"_emaApprovals":[],"_faersSignals":[{"count":6,"reaction":"EYE IRRITATION"},{"count":6,"reaction":"PRODUCT CONTAMINATION MICROBIAL"},{"count":5,"reaction":"DRY EYE"},{"count":4,"reaction":"EYE PAIN"},{"count":3,"reaction":"CHORIORETINITIS"},{"count":3,"reaction":"CHOROIDAL NEOVASCULARISATION"},{"count":3,"reaction":"ENTERITIS"},{"count":3,"reaction":"EPIRETINAL MEMBRANE"},{"count":3,"reaction":"EYE NAEVUS"},{"count":3,"reaction":"FLANK PAIN"}],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%"],"phase":"marketed","status":"active","brandName":"Systane Ultra Preservative Free","genericName":"Systane Ultra Preservative Free","companyName":"Laboratorios Sophia S.A de C.V.","companyId":"laboratorios-sophia-s-a-de-c-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Systane Ultra Preservative Free is an artificial tear solution that lubricates and protects the ocular surface to relieve dry eye symptoms. Used for Dry eye disease / 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}}