Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in Ocular comfort
研究概览
简要总结
In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.
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
- •Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD
排除标准
- •Treated with antibiotic eye drops in the month prior to enrollment
- •History of fluoroquinolone allergy
- •Asymmetric ocular disease
研究组 & 干预措施
Arm 1: Eye treated with Vigamox
-The participant will be instructed to use one drop from each bottle four times per day for 7 days
干预措施: Vigamox (Drug)
Arm 2: Eye treated with placebo
-The participant will be instructed to use one drop from each bottle four times per day for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Ocular comfort
时间窗: First clinic visit through second clinic visit (estimated to be 9-14 days)
* Ocular comfort will be rated by the participant for each eye on a 0-10 Visual Analog Scale * 0=no discomfort and 10=worst discomfort
次要结局
- Change in Ocular Surface Disease Index (OSDI) score(First clinic visit through second clinic visit (estimated to be 9-14 days))
- Change in Visual acuity(First clinic visit through second clinic visit (estimated to be 9-14 days))
- Change in the Degree of Conjunctival injection(First clinic visit through second clinic visit (estimated to be 9-14 days))
- Change in Corneal/conjunctival punctate epithelial erosions(First clinic visit through second clinic visit (estimated to be 9-14 days))
- Change in Culture results(First clinic visit through second clinic visit (estimated to be 9-14 days))