JPRN-jRCT2080220651未知3 期
ong Term Administration Study of OPC-12759 Ophthalmic Suspension in dry eye patients
Otsuka Pharmaceuticals Co., Ltd.0 个研究点目标入组 153 人开始时间: 2009年1月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1.Out patient;
- •2.Ocular discomfort severity is moderate to severe;
- •3.Cornaeal-conjunctival damage is moderate to severe;
- •4.Unanaesthetized Schirmer's test score of 5mm/5 minutes or less, or tear breakup time is 5 seconds or less;
- •5.Best corrected visual acuity of 0.2 or better in both eyes.
排除标准
- •1.Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
- •2.Ocular hypertension patient or glaucoma patient with ophthalmic solution;
- •3.Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
- •4.Anticipated use of contact lens during the study;
- •5.Patient with punctal plug;
- •6.Any history of ocular surgery within 12 months;
- •7.Female patients who are pregnant, possibly pregnant or breast feeding;
- •8.Known hypersensitivity to any component of the study drug or procedual medications;
- •9.Receipt of any investigational product within 4 months.
研究者
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