NCT04108286撤回不适用
Ex-vivo Adhesion of Bacteria to Different Contact Lens Materials
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Bacterial adhesion of clinical isolates of P. aeruginosa
研究概览
简要总结
This is a single-site, 4-visit, contralateral, dispensing, open-label, randomized study. Each eligible subject will be randomized into one of two sequence groups to wear two lens types contralaterally (Test on the right eye and Control on left eye or vice versa).
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
- None
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.
- •Between 18 and 45 (inclusive) years of age at the time of screening.
- •Be a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
- •Have a pair of spectacles with corrected vision of 20/40 or better in each eye or uncorrected vision is 20/40 or better in each eye
- •The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in each eye.
- •The subject has a best-corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study.
- •Currently pregnant or breastfeeding.
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
- •Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Multifocal, toric or extended wear contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Any ocular infection.
- •Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the EFRON scale (Appendix G), any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
结局指标
主要结局
Bacterial adhesion of clinical isolates of P. aeruginosa
时间窗: up to 2-week follow-up
Evaluation of the bacterial adhesion of 2 strains of bacteria, P. aeruginosa, on worn lenses based on the number of viable bacteria on the lens measured in colony forming unit (CFU).
次要结局
- Uptake of Lysozyme on worn lenses(up to 2-week follow-up)
研究者
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