A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
研究概览
简要总结
To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
详细描述
0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
- •Patients with type I reactions defined by skin testing, antibody measurement, etc.
- •Age over 6 years old
排除标准
- •Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
- •Subjects needed to wear contact lenses during treatment period on a testing eye
- •Subjects complicating an eye infection
研究组 & 干预措施
1
FK506 ophthalmic suspension
干预措施: FK506 (Drug)
2
Base of eye drops
干预措施: placebo (Drug)
结局指标
主要结局
Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
时间窗: 4 weeks
次要结局
- The improvement rate of subjective symptoms(4 weeks)
- Subjective symptom score (Visual Analog Scale)(4 weeks)
- Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign(Week 1, 2 and 4)