Phase III study of Efficacy and Safety of SJP-0118 in bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion. - Clinical study of SJP-0118 in extraocular bacterial infections.

Senju Pharmaceutical co.,ltd.0 个研究点目标入组 45 人开始时间: 2015年11月9日最近更新: 2023年10月17日

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•1) Subjects with suspected fungal, viral, or Acanthamoeba infection. 2) Subjects with suspected allergic conjunctivitis. 3) History of recurrent corneal erosion syndrome. 4) Any corneal epithelial loss, specifically any corneal ulcer (except for superficial punctate keratitis). 5) Subject with best-corrected visual acuity equal to or less than 0.2 in both eyes. 6) Subject need to use concomitant therapy during the study. 7) Use of any antibiotic (systemic, topical or dermally around eyelid) within 1 week of enrollment. 8) Use of any corticosteroid or nonsteroidal antiinflammatory drug (systemic of topical). 9) Ocular surgery within the past 90 days. 10) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders. 11) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications. 12) Willing to use contact lens or punctual plug during the study. 13) Pregnant, nursing, possibility of pregnancy or hope for the pregnancy during the study. 14) Participation in any other clinical study. 15) History of use azithromycin eye drops.

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