Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Coopervision, Inc.2 个研究点分布在 1 个国家目标入组 40 人开始时间: 2017年6月23日最近更新: 2019年9月12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: Coopervision, Inc.
入组人数: 40
试验地点: 2
主要终点: Visual Acuity Using logMAR

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 study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

详细描述

This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

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 40 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•They are of aged 18-40 and have 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.
•They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
•They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
•They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
•They currently use soft contact lenses or have done so in the previous six months.

排除标准

•They have an ocular disorder which would normally contra-indicate contact lens wear.
•They have a systemic disorder which would normally contra-indicate contact lens wear.
•They are using any topical medication such as eye drops or ointment.
•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 lactating.
•They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
•They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
•They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

研究组 & 干预措施

Ocufilcon B

Active Comparator

Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.

干预措施: Omafilcon A (Device)

Omafilcon A

Active Comparator

Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.

干预措施: Methafilcon A IV (Device)

Omafilcon A

Active Comparator

Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.

干预措施: Ocufilcon B (Device)

Methafilcon A IV

Active Comparator

Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.

干预措施: Omafilcon A (Device)

Ocufilcon B

Active Comparator

Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.

干预措施: Methafilcon A IV (Device)

Methafilcon A IV

Active Comparator

Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.

干预措施: Ocufilcon B (Device)