A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder - A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Senju Pharmaceutical Co.,Ltd.0 个研究点目标入组 90 人开始时间: 2018年9月19日最近更新: 2023年10月17日

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•1)Patients with prior ocular instillation of SJP-0035 2)Patients who currently have punctal occlusions inserted or with surgical punctal closure 3)Patients with best corrected visual acuity =< 0.2 4)Patients with corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea 5)Patients with any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures 6)Patients with removal of punctal occlusions within the last 14 days 7)Patients with previous intraocular surgery within the last 28 days 8)Patients with previous refractive surgery within the last 180 days 9)Patients with use of any ocular medication within the last 28 days 10)Patients who need the treatment for possibly improving ocular symptoms such as eye wash, lid hygiene, warm compress or massage, in either eye within 14 days prior to the first dose of study drug through the duration of the study 11)Patients who has a known hypersensitivity or significant adverse drug reaction to PPAR agonists, related compounds or any ingredients of drugs used in this study 12)Presence of a cancer or a serious systemic disease

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