NCT00128245已完成2 期
A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
研究概览
简要总结
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of artificial tear use
- •Moderate to severe signs of dry eye
- •Moderate to severe ocular discomfort
排除标准
- •Patients with uncontrolled systemic or ocular diseases.
- •Have any history of refractive surgery
- •Use any topical ocular medications other than those dispensed for the study, during the study
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Pimecrolimus 0.3%
Experimental
ASM981 0.3%
干预措施: Pimecrolimus (Drug)
Pimecrolimus 1%
Experimental
ASM981 1%
干预措施: Pimecrolimus (Drug)
Vehicle with carbopol
Placebo Comparator
干预措施: Vehicle (Drug)
Vehicle without carbopol
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
次要结局
- 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
- Global assessment of efficacy and tolerability
研究者
研究点 (1)
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