The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
研究概览
简要总结
To determine if the use of Xiidra® reduces ocular surface inflammation in preoperative and postoperative cataract patients.
详细描述
Single-center, prospective, randomized, investigator-initiated study
250 cataract patients, aged 60 or older, will be tested for ocular surface inflammation with the InflammaDry® immunoassay
Patients with bilateral positive MMP-9 will be randomized into a group treated with Xiidra two weeks preoperatively and six weeks postoperatively or a group not treated with Xiidra
The investigator hypothesizes that treatment with Xiidra prior to routine cataract surgery will significantly improve the quality of keratometry readings and BCVA.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Positive for MMP-9 bilaterally as assessed by the Inflammadry assay
排除标准
- •Negative Inflammadry assay in either eye
- •Active diabetic retinopathy, uncontrolled glaucoma, uncontrolled uveitic inflammation
- •Ocular surface diseases that might confound the interpretation of the InflammaDry assay
研究组 & 干预措施
Lifitegrast
One drop of Lifitegrast Ophthalmic Solution 5% will be instilled into each eye twice daily (approximately 12 hours apart) using a single-use conainer.
干预措施: Lifitegrast 5% Ophthalmic Solution (Drug)
结局指标
主要结局
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
时间窗: 12 weeks
Compare the conversion rates of bilateral positive MMP-9 to negative in pre-cataract and post-cataract patients receiving treatment with Xiidra versus no Xiidra
次要结局
未报告次要终点