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临床试验/JPRN-jRCT2080220651
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

发起方
Otsuka Pharmaceuticals Co., Ltd.

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