JPRN-jRCT2080221875已完成3 期
Confirmatory study of OPC-12759 Ophthalmic Solution
Otsuka Pharmaceuticals Co., Ltd.0 个研究点目标入组 209 人开始时间: 2012年8月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
研究概览
简要总结
In conclusion, 2% OPC-12759 ophthalmic solution is effective for the treatment of dry eye and shows comparable efficacy to that of 2% OPC-12759 ophthalmic suspension. There were no significant safety concerns with regard to 2% OPC-12759 ophthalmic solution in the present study.
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. Subjective complaint of dry eye that has been present for minimum 20 months
- •3. Ocular discomfort severity is moderate to severe
- •4. Corneal - conjunctival damage is moderate to severe
- •5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
- •6. 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 dry eye
- •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 procedural medications
- •9. Receipt of any investigational product within 4 months
研究者
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