NCT00567918已完成3 期
Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in 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
- 52
- 主要终点
- Safety
研究概览
简要总结
To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis
详细描述
To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
- •Patients who wish to receive continuous administration of FK506 ophthalmic suspension
排除标准
- •Subjects who needed prohibited concomitant therapy at the initiation of the study
- •Subjects who needed to wear contact lenses during treatment period on a testing eye
- •Subjects with complicating an eye infection
研究组 & 干预措施
1
Experimental
FK506 ophthalmic suspension
干预措施: FK506 (Drug)
结局指标
主要结局
Safety
时间窗: length of study
次要结局
- The mean change from the baseline (before the treatment) in total score for objective clinical signs(length of study)
- Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign(Length of study)
- Subjective symptom score (Visual Analog Scale)(Length of study)
- The improvement rate(Length of study)
研究者
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