A Dispensing Clinical of Fanfilcon A Lens Against Lotrafilcon B Lens Over 1 Month Wear Per Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Subjective Preference
研究概览
简要总结
This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.
详细描述
This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.
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
- •A person is eligible for inclusion in the study if he/she:
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
- •Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day);
- •Demonstrates an acceptable fit with the study lenses.
排除标准
- •A person will be excluded from the study if he/she:
- •Is participating in any concurrent clinical or research study;
- •Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
- •Is aphakic;
- •Has undergone refractive error surgery;
- •For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Subjective Preference
时间窗: 1 month
Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving.
Subjective Comfort
时间窗: Baseline, 1 month
Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).
Lens Wettability
时间窗: Baseline, 1 month
Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
Surface Deposits
时间窗: Baseline, 1 month
Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)
次要结局
未报告次要终点