{"id":"cyclosporine-0-05-eye-drops","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Ocular irritation/burning"},{"rate":"5-15","effect":"Conjunctival hyperemia"},{"rate":"5-10","effect":"Blurred vision"},{"rate":"5-10","effect":"Foreign body sensation"}]},"_chembl":{"chemblId":"CHEMBL406352","moleculeType":"Small molecule","molecularWeight":"1202.63"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cyclosporine is a calcineurin inhibitor that blocks T-cell proliferation and the production of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) at the ocular surface. By reducing immune-mediated inflammation, it increases tear production and improves tear film stability in patients with keratoconjunctivitis sicca (dry eye syndrome).","oneSentence":"Cyclosporine suppresses T-cell activation and cytokine production to reduce ocular surface inflammation in dry eye disease.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:31:32.514Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe dry eye disease (keratoconjunctivitis sicca)"}]},"trialDetails":[{"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":"NCT04795752","phase":"NA","title":"Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)","status":"COMPLETED","sponsor":"Sight Sciences, Inc.","startDate":"2021-04-28","conditions":"Dry Eye, Meibomian Gland Dysfunction","enrollment":345},{"nctId":"NCT06981104","phase":"NA","title":"Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT","status":"COMPLETED","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2024-11-18","conditions":"Dry Eye Disease (DED), Asthenopia","enrollment":60},{"nctId":"NCT07171710","phase":"NA","title":"Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom","status":"ENROLLING_BY_INVITATION","sponsor":"Tianjin Eye Hospital","startDate":"2024-03-01","conditions":"Dry Eye Disease","enrollment":30},{"nctId":"NCT04734197","phase":"PHASE2","title":"A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Surface Ophthalmics, Inc.","startDate":"2021-01-11","conditions":"Dry Eye Disease","enrollment":349},{"nctId":"NCT06876116","phase":"PHASE4","title":"Once-daily Fluorometholone vs Twice-daily Cyclosporine in Dry Eye Disease","status":"COMPLETED","sponsor":"Korea University Anam Hospital","startDate":"2022-09-01","conditions":"Dry Eye Disease (DED)","enrollment":32},{"nctId":"NCT06824844","phase":"PHASE4","title":"The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease","status":"COMPLETED","sponsor":"Peking University Third Hospital","startDate":"2021-12-02","conditions":"Dry Eye","enrollment":60},{"nctId":"NCT04918823","phase":"PHASE1, PHASE2","title":"Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device","status":"COMPLETED","sponsor":"Boston Sight","startDate":"2021-07-15","conditions":"Ocular Surface Disease","enrollment":10},{"nctId":"NCT06624384","phase":"PHASE1","title":"Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024","status":"NOT_YET_RECRUITING","sponsor":"Mohsen Pourazizi","startDate":"2024-10-30","conditions":"Ocular Surface Symptom, Ocular Surface Disease, Eye Pain","enrollment":150},{"nctId":"NCT05743764","phase":"PHASE3","title":"HU007 in Patients with Dry Eye Syndrome","status":"COMPLETED","sponsor":"Huons Co., Ltd.","startDate":"2023-03-23","conditions":"Dry Eye Disease","enrollment":328},{"nctId":"NCT05720715","phase":"PHASE4","title":"Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis","status":"COMPLETED","sponsor":"Farwaniya Hospital","startDate":"2022-01-01","conditions":"Outcomes of Cyclosporine Eye Drops in Herpetic Keratitis","enrollment":30},{"nctId":"NCT04357795","phase":"PHASE4","title":"Effect of Cequa™ in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries Limited","startDate":"2020-06-29","conditions":"Dry Eye Disease","enrollment":135},{"nctId":"NCT05733624","phase":"PHASE2","title":"Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis","status":"COMPLETED","sponsor":"SCAI Therapeutics","startDate":"2023-01-05","conditions":"Dry Eye Syndromes","enrollment":116},{"nctId":"NCT05627947","phase":"PHASE1","title":"Comparison Between Topical Mitomycin C and Cyclosporine","status":"COMPLETED","sponsor":"Egymedicalpedia","startDate":"2021-01-01","conditions":"Pterygium","enrollment":57},{"nctId":"NCT06043908","phase":"PHASE4","title":"The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye","status":"UNKNOWN","sponsor":"Peking University Third Hospital","startDate":"2022-08-31","conditions":"Dry Eye","enrollment":60},{"nctId":"NCT06013436","phase":"","title":"AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye","status":"COMPLETED","sponsor":"Chengdu University of Traditional Chinese Medicine","startDate":"2022-06-01","conditions":"Sjogren's Syndrome, Dry Eye, Ocular Surface Disease","enrollment":30},{"nctId":"NCT05771012","phase":"NA","title":"Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.","status":"COMPLETED","sponsor":"Farwaniya Hospital","startDate":"2021-01-01","conditions":"Management of Punctal Stenosis","enrollment":42},{"nctId":"NCT04127851","phase":"PHASE4","title":"Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients","status":"COMPLETED","sponsor":"Taejoon Pharmaceutical Co., Ltd.","startDate":"2019-11-12","conditions":"Dry Eye, Dry Eye Syndromes","enrollment":438},{"nctId":"NCT05353101","phase":"PHASE1","title":"Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Nanchang University","startDate":"2020-07-01","conditions":"Vernal Keratoconjunctivitis, Cyclosporine 0.05% Eye Drops","enrollment":48},{"nctId":"NCT05294666","phase":"PHASE4","title":"Evaluation of 0.05% CsA and 0.1% FK506 Eye Drops in Ocular GVHD Treatment","status":"COMPLETED","sponsor":"Peking University Third Hospital","startDate":"2020-04-01","conditions":"Graft Versus Host Disease in Eye","enrollment":89},{"nctId":"NCT05245604","phase":"PHASE3","title":"Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients","status":"UNKNOWN","sponsor":"Taejoon Pharmaceutical Co., Ltd.","startDate":"2020-06-19","conditions":"Dry Eye Syndrome","enrollment":182},{"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":"NCT03597139","phase":"PHASE2","title":"Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Aurinia Pharmaceuticals Inc.","startDate":"2018-08-13","conditions":"Dry Eye","enrollment":100},{"nctId":"NCT02004067","phase":"PHASE4","title":"Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease","status":"COMPLETED","sponsor":"Federal University of São Paulo","startDate":"2013-01","conditions":"Primary Sjogren Syndrome, Secondary Sjogren Syndrome, Aqueous Deficient Dry Eye Disease","enrollment":100},{"nctId":"NCT04384991","phase":"PHASE3","title":"HU007 Eye Drops in Patients With Dry Eye Syndrome","status":"COMPLETED","sponsor":"Huons Co., Ltd.","startDate":"2019-05-03","conditions":"Dry Eye Syndromes","enrollment":216},{"nctId":"NCT03461575","phase":"PHASE3","title":"Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome","status":"COMPLETED","sponsor":"Huons Co., Ltd.","startDate":"2018-01-22","conditions":"Dry Eye Syndrome","enrollment":209},{"nctId":"NCT02199964","phase":"NA","title":"The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface","status":"TERMINATED","sponsor":"Baylor College of Medicine","startDate":"2014-03","conditions":"Dry Eye","enrollment":4},{"nctId":"NCT02617667","phase":"PHASE2","title":"CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)","status":"COMPLETED","sponsor":"Novaliq GmbH","startDate":"2016-01","conditions":"Dry Eye Syndromes","enrollment":207},{"nctId":"NCT01817582","phase":"PHASE2","title":"Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2013-05-17","conditions":"Keratoconjunctivitis Sicca","enrollment":102},{"nctId":"NCT03865888","phase":"PHASE3","title":"Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome","status":"COMPLETED","sponsor":"Pavly Moawd","startDate":"2018-10-30","conditions":"Dry Eye, Sjogren Syndrome","enrollment":60},{"nctId":"NCT00827255","phase":"","title":"Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%","status":"COMPLETED","sponsor":"Allergan","startDate":"2009-01","conditions":"Dry Eye Disease","enrollment":35},{"nctId":"NCT02121847","phase":"PHASE4","title":"Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy","status":"COMPLETED","sponsor":"Allergan","startDate":"2014-04-03","conditions":"Dry Eye Syndromes","enrollment":40},{"nctId":"NCT03666884","phase":"PHASE4","title":"The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome","status":"COMPLETED","sponsor":"Seref istek","startDate":"2015-10-10","conditions":"Dry Eye Syndrome","enrollment":36},{"nctId":"NCT01768312","phase":"PHASE3","title":"Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2012-08-23","conditions":"Dry Eye Syndromes","enrollment":84},{"nctId":"NCT02917512","phase":"PHASE2","title":"Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome","status":"COMPLETED","sponsor":"Huons Co., Ltd.","startDate":"2016-03","conditions":"Dry Eye Syndrome","enrollment":114},{"nctId":"NCT00987467","phase":"NA","title":"Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2007-08","conditions":"Atopic Keratoconjunctivitis","enrollment":12},{"nctId":"NCT02554981","phase":"PHASE4","title":"Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®","status":"COMPLETED","sponsor":"Allergan","startDate":"2015-07-21","conditions":"Dry Eye Syndromes","enrollment":51},{"nctId":"NCT00553735","phase":"PHASE4","title":"The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye","status":"TERMINATED","sponsor":"Massachusetts Eye and Ear Infirmary","startDate":"2007-08","conditions":"Dry Eye","enrollment":8},{"nctId":"NCT01064830","phase":"PHASE2","title":"Topical Cyclosporine Suspension for the Treatment of Brittle Nails","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2010-02","conditions":"Brittle Nail Syndrome","enrollment":21},{"nctId":"NCT00405431","phase":"NA","title":"Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?","status":"COMPLETED","sponsor":"Wills Eye","startDate":"2004-03","conditions":"Glaucoma","enrollment":43},{"nctId":"NCT01198782","phase":"PHASE4","title":"Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2010-09","conditions":"Dry Eye Syndrome","enrollment":48},{"nctId":"NCT01319773","phase":"PHASE1","title":"Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye","status":"COMPLETED","sponsor":"Allergan","startDate":"2010-11","conditions":"Dry Eye Syndromes","enrollment":44},{"nctId":"NCT01804361","phase":"PHASE3","title":"Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes","status":"COMPLETED","sponsor":"DH Bio Co., Ltd.","startDate":"2013-03","conditions":"Dry Eye Syndromes","enrollment":90},{"nctId":"NCT02492412","phase":"PHASE3","title":"Efficacy and Safety of HE10 for Dry Eye Syndrome","status":"COMPLETED","sponsor":"Huons Co., Ltd.","startDate":"2013-05","conditions":"Dry Eye Syndrome","enrollment":101},{"nctId":"NCT02461719","phase":"PHASE3","title":"Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes","status":"COMPLETED","sponsor":"Taejoon Pharmaceutical Co., Ltd.","startDate":"2014-01","conditions":"Dry Eye Syndromes","enrollment":158},{"nctId":"NCT02229955","phase":"PHASE3","title":"Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-12","conditions":"Dry Eye Syndromes","enrollment":86},{"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":"NCT01109056","phase":"PHASE2","title":"Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium","status":"COMPLETED","sponsor":"Allergan","startDate":"2010-06","conditions":"Pterygium","enrollment":115},{"nctId":"NCT00717418","phase":"","title":"Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease","status":"COMPLETED","sponsor":"Allergan","startDate":"2004-09","conditions":"Keratoconjunctivitis Sicca","enrollment":781},{"nctId":"NCT01488396","phase":"PHASE4","title":"Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2007-02","conditions":"Stevens-Johnson Syndrome","enrollment":31},{"nctId":"NCT00705510","phase":"PHASE4","title":"Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction","status":"COMPLETED","sponsor":"Mahidol University","startDate":"2008-05","conditions":"Meibomian Gland Dysfunction","enrollment":70},{"nctId":"NCT00426023","phase":"PHASE3","title":"Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis","status":"COMPLETED","sponsor":"Campus Bio-Medico University","startDate":"2007-02","conditions":"Vernal Keratoconjunctivitis","enrollment":48},{"nctId":"NCT00797030","phase":"PHASE4","title":"Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus","status":"UNKNOWN","sponsor":"Universidade Federal do Rio de Janeiro","startDate":"2006-10","conditions":"Dry Eye Syndromes, HIV Seropositivity","enrollment":20},{"nctId":"NCT00704275","phase":"PHASE4","title":"Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes","status":"UNKNOWN","sponsor":"Chulalongkorn University","startDate":"2007-06","conditions":"Dry Eye","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["fluorometholone 0.1%"],"phase":"marketed","status":"active","brandName":"Cyclosporine 0.05% eye drops","genericName":"Cyclosporine 0.05% eye drops","companyName":"Second Affiliated Hospital of Nanchang University","companyId":"second-affiliated-hospital-of-nanchang-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cyclosporine suppresses T-cell activation and cytokine production to reduce ocular surface inflammation in dry eye disease. Used for Moderate to severe dry eye disease (keratoconjunctivitis sicca).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}