Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types

Johnson & Johnson Vision Care, Inc.10 个研究点分布在 1 个国家目标入组 130 人开始时间: 2018年2月7日最近更新: 2019年10月2日

适应症

干预措施

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: 130
试验地点: 10
主要终点: Subject Comfort

研究概览研究设计入排标准研究组 & 干预措施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 multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period crossover, dispensing, five-visit study to gain clinical insights of the study lenses and solutions.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 69 Years（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:
•Subjects must be 18-69 years of age (inclusive).
•Subjects must be habitual disposable hydrogel or silicone hydrogel (1-day, 2-week, or monthly replacement schedule) soft lens wearer in both eyes. Habitual is defined as at least one (1) month of contact lens wear where the lenses are worn for a minimum of six (6) hours per day and a minimum of five (5) days per week.
•Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
•The subject's refractive sphere (vertexed) must be between -1.00 and -6.00 D in each eye.
•The subject's refractive cylinder must be less than or equal to -1.00 D in each eye.
•The subject must have normal eyes (i.e., no ocular medications or infections of any type).
•Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
•Subjects must read, understand, and sign the Statement of Informed Consent.
•Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

排除标准

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•Currently pregnant or breast-feeding.
•Any ocular or systemic allergies or disease which may interfere with contact lens wear (at the discretion of the investigator).
•Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
•Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (eg, HIV), by self-report.
•Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
•Grade 2 or greater corneal staining or conjunctival injection on the FDA scale.
•Clinically significant (Grade 3 or greater on the FDA scale) corneal edema, corneal vascularization, or any other abnormalities of the cornea (excluding corneal staining) which would contraindicate contact lens wear.
•Clinically significant (Grade 3 or greater on the FDA scale) tarsal abnormalities which might interfere with contact lens wear.
•Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
•Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
•History of any ocular or corneal surgery (eg, RK, PRK, LASIK).
•Habitual contact lens wear modality as extended wear.
•Participation in any pharmaceutical or medical device related clinical trial within 7 days prior to study enrollment.
•History of binocular vision abnormality or strabismus.
•Habitual wearers of rigid gas permeable lens within the past 3 months.
•Employees of investigational clinic (investigator, coordinator, and technician etc.) or family members of employees of the investigational clinic by self-report