Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Comfort Preference
研究概览
简要总结
Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.
详细描述
Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 17 years of age for Canada and 18 years of age for the USA 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 -0.50 to -6.00 diopters and
- •Astigmatism: between -1.25 to -2.00 and
- •Axis: 180 ± 20 degrees
- •Are willing to wear contact lens in both eyes;
- •Have manifest refraction visual acuities (VA) equal to or better than logMAR 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
- •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
enfilcon A
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
干预措施: fanfilcon A (Device)
enfilcon A
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
干预措施: enfilcon A (Device)
fanfilcon A
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
干预措施: fanfilcon A (Device)
fanfilcon A
Each subject randomized to wear either the test or control as a matched pair and cross over to the second matched pair.
干预措施: enfilcon A (Device)
结局指标
主要结局
Comfort Preference
时间窗: Dispensing (Baseline) and 2 weeks
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Comfort (Subjective Rating Scale)
时间窗: Dispensing (Baseline) and 2 weeks
Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
次要结局
未报告次要终点