Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display

Johnson & Johnson Vision Care, Inc.2 个研究点分布在 1 个国家目标入组 55 人开始时间: 2021年5月10日最近更新: 2023年7月21日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Johnson & Johnson Vision Care, Inc.
入组人数: 55
试验地点: 2
主要终点: Visual Analogue Scales (VAS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects will proceed to either a low-sphere or high-sphere arm based on refraction measurements in the baseline assessment.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Device Feasibility
盲法: None

入排标准

年龄范围: 18 Years 至 40 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 35 (inclusive) years of age at the time of screening.
•They agree not to participate in other clinical research while enrolled on this study.
•They have worn the same brand of soft contact lenses at least eight hours per day for at least two days per week over the previous three months.
•They own a wearable pair of spectacles if needed for distance vision correction (by self-report).
•They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
•In a pre-study screening assessment, they must have a CVS-Q score of 4 or less (asymptomatic group) or 6 or greater (symptomatic group).
•They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
•They have spherical contact lens prescription in the range +1.00 to -6.00 DS (based on the calculated ocular refraction).
•They have up to maximum of 0.75 DC of refractive astigmatism (based on the calculated ocular refraction).

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 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.
•Any known hypersensitivity or allergic reaction to sodium fluorescein.
•Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
•Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
•Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•They have any existing binocular vision anomalies such as strabismus or have been prescribed prisms in their spectacles based on self-report, or in the opinion of the investigator exhibit signs of suppression during binocular vision testing.
•Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which in the investigator's opinion would contraindicate contact lens wear.