NCT04186858已完成不适用
Assessment of Levels of Intracellular Cytokines and Markers in Cells Recovered From the Anterior Eye (Phase 4)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Cells
研究概览
简要总结
This is a single-visit, non-randomized, bilateral, cross-sectional study. In a pre-screening assessment, potential subjects will be invited to complete a web-based questionnaire that is validated to determine symptomatic vs asymptomatic contact lens wearers. Results of this questionnaire will be used to determine whether subjects are eligible to proceed to Visit 1. During Visit 1, cell samples will be collected from the front surface of the subject's eyes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（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:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be between 18 and 45 years of age (inclusive) at the time of screening
- •They have worn the same brand of soft contact lenses for at least the previous three months.
- •They agree not to participate in other clinical research trials for the duration of this study.
- •In a pre-study screening assessment, they must have a CLDEQ-8 score of 10 or less (asymptomatic group) or 20 or higher (symptomatic group).
- •They possess a wearable pair of distance glasses and agree to bring these to the study visit (if needed for distance vision correction).
- •They can attain a high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses.
- •Their habitual contact lenses fit satisfactorily.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
- •They have an ocular disorder which would normally contraindicate contact lens wear.
- •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 have taken part in any other contact lens or care solution clinical trial research, within two weeks prior to starting this study.
- •They are 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.
- •History of allergic reaction to sodium fluorescein or topical anesthetic.
- •Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •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: ~6 hours of contact lens wear time
The frequency count of cells will be summarized within the category
Types of Cells
时间窗: ~6 hours of contact lens wear 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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