NCT00814515已完成3 期
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen SAS
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Corneal fluorescein staining (on modified Oxford scale)
研究概览
简要总结
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
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
- Triple (Participant, Care Provider, Investigator)
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
- •Males or females 18 years of age or greater.
- •At baseline, moderate to severe dry eye condition persisting despite conventional management.
排除标准
- •Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
- •Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
- •Any other ocular diseases requiring topical ocular treatment during the study period.
- •Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
- •Participation in another clinical study at the same time as the present study.
研究组 & 干预措施
1
Active Comparator
Ciclosporin 0.1%
干预措施: NOVA22007 (Ciclosporin 0.1%) (Drug)
2
Placebo Comparator
Vehicle
干预措施: NOVA22007 (Drug)
结局指标
主要结局
Corneal fluorescein staining (on modified Oxford scale)
时间窗: Approximately 26 weeks
Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100%
时间窗: Approximately 26 weeks
次要结局
- • Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to(Approximately 26 weeks)
研究者
研究点 (1)
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