{"id":"csa-ophthalmic-gel","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation/burning"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Foreign body sensation"}]},"_chembl":{"chemblId":"CHEMBL3038082","moleculeType":"Protein","molecularWeight":"1361.89"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cyclosporine A is a calcineurin inhibitor that blocks T-cell proliferation and the production of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) implicated in dry eye pathogenesis. The ophthalmic gel formulation delivers the drug topically to the ocular surface, reducing inflammation and promoting tear production in patients with moderate-to-severe dry eye disease.","oneSentence":"CsA (cyclosporine A) ophthalmic gel suppresses T-cell activation and reduces inflammatory cytokine production in the eye to treat dry eye disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:07:56.393Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease (moderate to severe)"}]},"trialDetails":[{"nctId":"NCT07021495","phase":"","title":"SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2025-07-29","conditions":"Chronic Spontaneous Urticaria (CSU), Hidradenitis Suppurativa (HS), Psoriasis (PsO)","enrollment":840},{"nctId":"NCT06766357","phase":"PHASE3","title":"A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease","status":"RECRUITING","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2025-04-03","conditions":"Moderate to Severe Dry Eye","enrollment":360},{"nctId":"NCT06942793","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Treatment With CsA-PG Ophthalmic Gel in Dry Eye Patients","status":"NOT_YET_RECRUITING","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2025-05-20","conditions":"Dry Eye Disease","enrollment":396},{"nctId":"NCT06392438","phase":"PHASE3","title":"Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users","status":"RECRUITING","sponsor":"Université de Sherbrooke","startDate":"2024-04-25","conditions":"Dry Eye, Contact Lens Complication","enrollment":44},{"nctId":"NCT04541888","phase":"PHASE3","title":"Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease","status":"COMPLETED","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2020-11-05","conditions":"Dry Eye","enrollment":644},{"nctId":"NCT03287635","phase":"PHASE4","title":"Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Toyos Clinic","startDate":"2018-07-01","conditions":"Dry Eye Disease","enrollment":19},{"nctId":"NCT03676335","phase":"PHASE2","title":"Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye","status":"COMPLETED","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2018-05-09","conditions":"Dry Eye","enrollment":240},{"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":"NCT02028312","phase":"PHASE4","title":"A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®","status":"WITHDRAWN","sponsor":"Edward Holland, MD","startDate":"2014-01","conditions":"Dry Eye Disease","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CsA gel"],"phase":"phase_3","status":"active","brandName":"CsA Ophthalmic Gel","genericName":"CsA Ophthalmic Gel","companyName":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","companyId":"zhaoke-guangzhou-ophthalmology-pharmaceutical-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CsA (cyclosporine A) ophthalmic gel suppresses T-cell activation and reduces inflammatory cytokine production in the eye to treat dry eye disease. Used for Dry eye disease (moderate to severe).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}