NCT00818324已完成3 期
Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out patient;
- •Ocular discomfort severity is moderate to severe;
- •Corneal-conjunctival damage is moderate to severe;
- •Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
- •Best corrected visual acuity of 0.2 or better in both eyes.
排除标准
- •Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
- •Ocular hypertention patient or glaucoma patient with ophthalmic solution;
- •Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
- •Anticipated use of contact lens during the study;
- •Patient with punctal plug;
- •Any history of ocular surgery within 12 months;
- •Female patients who are pregnant, possibly pregnant or breast feeding;
- •Known hypersensitivity to any component of the study drug or procedual medications;
- •Receipt of any investigational product within 4 months.
研究组 & 干预措施
OPC-12759 Ophthalmic suspension
Experimental
Instillation, 4times/day
干预措施: OPC-12759 Ophthalmic suspension (Drug)
结局指标
主要结局
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
时间窗: Baseline, Week2, Week4, Week28, Week52
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
次要结局
未报告次要终点
研究者
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