NCT03896100已完成不适用
Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 3)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Cells
研究概览
简要总结
This is a single arm, prospective, bilateral, non-randomized study that will be split into four elements. Element 1 will be an in vitro non-clinical study and described in the laboratory protocol. Elements 2, 3 and 4 will each be a single non-dispensing visit.
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
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •They are of legal age (18 years) and capacity to volunteer.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They agree not to participate in other clinical research for the duration of this study.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •They have had cataract surgery.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breast-feeding.
- •They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history or anaphylaxis or severe allergic reactions.
- •They have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
- •They are currently regularly (once per day or more) using oral or inhaled steroids or anti-inflammatory medications.
- •They are using any topical medications such as eye drops or ointments.
- •They are a current (i.e. within the last three months) contact lens wearer (wearing a lens in one or both eyes).
- •History of allergic reaction to sodium fluorescein or topical anesthetic.
- •They have Grade 3 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining (white light evaluation), tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- •Any active ocular infection or inflammation.
结局指标
主要结局
Number of Cells
时间窗: 1.5 hours duration of assessment time
The frequency count of cells will be summarized within the category.
Types of Cells
时间窗: 1.5 hours duration of assessment time
The percentage of types of cells will be summarized within the category.
次要结局
未报告次要终点
研究者
研究点 (1)
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