A phase III placebo-controlled comparative study of SJP-0118 in patients with bacterial conjunctivitis - A placebo-controlled comparative study in patients with bacterial conjunctivitis

Senju Pharmaceutical Co., Ltd.0 个研究点目标入组 640 人开始时间: 2017年4月28日最近更新: 2023年10月17日

适应症

试验速览

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•1) Possible ocular infection other than the trial indication 2) Possible allergic conjunctivitis or onset of its symptom during the study 3) Any history of recurrent erosion of cornea 4) Corneal findings of "+" or worse 5) Corrected visual acuity =<0.2 6) Instillation of any ophthalmic solution within 2 hours prior to the examinations on the start day of treatment 7) Systemic use, ocular instillation or topical dermal application around eyes of any antibiotic or synthetic antibacterial agent within one week prior to the start of treatment 8) Systemic use of corticosteroids or ocular instillation of corticosteroids or NSAIDs within one week prior to the start of treatment 9) Ocular surgery within 90 days prior to the start of treatment 10) Presence of a cancer or a serious systemic disease such as serious hepatic disorder, serious renal disorder, serious cardiovascular disease or serious endocrine system disease 11) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study, azithromycin or other macrolide antibiotics 12) Past ocular instillation of azithromycin

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