A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

CooperVision, Inc.1 个研究点分布在 1 个国家目标入组 23 人开始时间: 2015年9月1日最近更新: 2020年10月19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: 23
试验地点: 1
主要终点: Subjective Overall Preference

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 was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

详细描述

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•A person is eligible for inclusion in the study if they:
•Are at least 18 years of age and have full legal capacity to volunteer;
•Have read and signed an information consent letter;
•Are willing and able to follow instructions and maintain the appointment schedule;
•Are an adapted soft contact lens wearer;
•Require spectacle lens powers in both eyes;
•Sphere: between -1.75 to -6.00 diopters and
•Astigmatism: between -1.00 to -2.25 and
•Axis: 180 ± 20 degrees
•Are willing to wear contact lenses in both eyes;
•Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
•To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.

排除标准

•A person will be excluded from the study if they:
•Are participating in any concurrent clinical or research study;
•Have any known active* ocular disease and/or infection;
•Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
•Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
•Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
•Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
•Are aphakic;
•Have undergone refractive error surgery;

研究组 & 干预措施

Sapphire contact lenses

Experimental

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

干预措施: Sapphire contact lenses (Device)

senofilcon A

Active Comparator

Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

干预措施: senofilcon A contact lenses (Device)

结局指标

主要结局

Subjective Overall Preference

时间窗: 2 weeks

Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Subjective Assessment of Visual Quality

时间窗: 2 weeks

Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

Subjective Ratings for Comfort

时间窗: 2 weeks

Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

Subjective Ratings for Comfort Preference

时间窗: 2 weeks

Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

Subjective Assessment of Overall Satisfaction

时间窗: 2 weeks

Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

Subjective Ratings for Comfort