Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 4
- 主要终点
- Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
研究概览
简要总结
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
详细描述
The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
- •Burning or stinging
- •Sandy or gritty feeling
- •Foreign body sensation
- •Light sensitivity
- •Intermittent or fluctuating vision
- •Exclusion Criteria
- •Allergy to cornstarch or Dacron
- •Allergy to topical anesthetic or fluorescein dye
- •Prior eye injury, trauma, or ocular surgery within the last 3 months
- •Known blockage of the lacrimal drainage system
- •Contact lens wear in the last month
- •Previous corneal refractive surgery including RK, LASIK or PRK surgery
- •Have an active ocular infection or history of a recent ocular infection in the last month
- •Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
- •Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
- •Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
- •Pregnant or lactating
- •Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment
排除标准
- 未提供
结局指标
主要结局
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
时间窗: 20 minutes
Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
次要结局
未报告次要终点