NCT03426267已完成3 期
A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.
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
- 325
- 试验地点
- 19
- 主要终点
- Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
研究概览
简要总结
The efficacy and safety of SDN-037 twice daily will be evaluated and compared with vehicle for the treatment of inflammation and pain associated with ocular surgery.
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 (Participant, Care Provider)
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
- •Be at least 2 years of age on the date of assent or 18 years of age at the date of consent
- •Be able and willing to follow study instructions and complete all required visits
- •Females of childbearing potential must not be pregnant (as confirmed by a negative urine pregnancy test
- •Able to self-instill the IP or have a caregiver available to instil all doses of the IP
排除标准
- •Any known allergy or hypersensitivity to difluprednate therapy
- •An acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
- •Any active corneal pathology noted in the study eye
- •Currently suffering from alcohol and/or drug abuse
研究组 & 干预措施
vehicle
Placebo Comparator
干预措施: Placebo (Drug)
SDN-037
Experimental
干预措施: SDN-037 (Drug)
结局指标
主要结局
Subjects With an Anterior Chamber Cell Grade of 0 at Day 15
时间窗: Day 15
Grade Cell Count 0 0 1. 1-10 2. 11-20 3. 21-50 4. \> 50 ACC grade of 0 at the Day 15 visit was considered a responder to therapy ACC score of \>0 at Day 15 visit was considered a failure (or non-responder)
次要结局
- Subjects Who Achieve a Pain Score of 0 at Day 15(Day 15)
研究者
研究点 (19)
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