The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease (RINSE-A)
研究概览
详细说明
The objective is to determine whether irrigation of the bulbar conjunctiva, palpebral conjunctiva, conjunctival fornix, and the corneal surface reduces the inflammatory burden in patients with dry eye disease. The scientific premise is that inflammation contributes to the clinical symptoms of dry eye disease. By reducing the inflammatory mediators on the ocular surface, there may be a reduction in dry eye symptoms.
The primary endpoint is MMP-9 positivity. Secondary endpoints include CDES-Q, Ocular Itch Scale, and keratometry measurements.
The study population includes participants who have severe dry eye disease. The inclusion and exclusion criteria is described below. The goal is to recruit 150 patients, Including screen failures, a total of 250 participants will need to be screened for the study.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Srinivas S Kondapalli
- 电话号码:4123243010
- 邮箱:srini@rinsada.com
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15219
- 招聘中
- Everett and Hurite Ophthalmic Association
-
接触:
- Srinivas Kondapalli, MD
- 邮箱:srini@rinsada.com
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- MMP-9 Positivity in both eyes
Exclusion Criteria:
- Active ocular infection, including bacterial, viral, or fungal conjunctivitis Acute allergic conjunctivitis or severe seasonal ocular allergy flare History of autoimmune ocular surface disease (e.g., Sjögren syndrome, ocular cicatricial pemphigoid, Stevens-Johnson syndrome) Current use of topical anti-inflammatory medications, including corticosteroids, cyclosporine, lifitegrast, or topical NSAIDs within 14-30 days prior to enrollment Initiation of new ocular or systemic anti-inflammatory therapy during the study period Contact lens wear within 12-24 hours prior to testing Ocular surgery or laser procedures within the previous 3-6 months Current punctal plug use or punctal occlusion procedures within the prior 3 months Severe aqueous-deficient dry eye preventing adequate tear sample acquisition or reliable InflammaDry testing Use of preserved artificial tears within a specified washout period Eyelid abnormalities or active blepharitis requiring treatment Pregnancy or breastfeeding (optional depending on IRB requirements) History of hypersensitivity to saline irrigation or study materials Any systemic inflammatory disease judged by investigators to confound tear film MMP-9 level
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Control eye
|
|
|
实验性的:Treatment Eye
|
Irrigation via irrigating eyelid retractor
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MMP-9 Positivity
大体时间:3 Hours
|
Tear MMP-9 levels will be assessed using a point-of-care diagnostic assay.
Change from baseline to the specified follow-up visit will be analyzed.
|
3 Hours
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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