Daily Disposable Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
研究概览
简要总结
The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.
详细描述
This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
- •Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
- •Demonstrates an acceptable fit with the study lenses
排除标准
- •Is participating in any concurrent clinical or research study;
- •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 enrolment (by verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery;
研究组 & 干预措施
filcon II 3 and etafilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
干预措施: filcon II 3 (Device)
filcon II 3 and etafilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
干预措施: etafilcon A (Device)
filcon II 3 and nelfilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
干预措施: nelfilcon A (Device)
filcon II 3 and nelfilcon A
Participants were randomized to a test and control lens for each group in a contralateral design.
干预措施: filcon II 3 (Device)
结局指标
主要结局
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
时间窗: 6 hours
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
时间窗: Baseline visit
Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
时间窗: 3 hours
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
次要结局
- High Contrast Visual Acuity - Filcon II 3 and Etafilcon A(Baseline and 6 hours)
- Lens Comfort - Filcon II 3 and Nelficon A(Baseline, 3 hours, 6 hours)
- Lens Handling - Filcon II 3 and Etafilcon A(Baseline visit)
- Lens Dryness - Filcon II 3 and Etafilcon A(3 hours and 6 hours)
- Lens Fit, Tightness - Filcon II 3 and Etafilcon A(Baseline and 6 hours)
- Lens Surface Deposition - Filcon II 3 and Etafilcon A(6 hour)
- Lens Surface Deposition - Filcon II 3 and Nelfilcon A(6 hour)
- Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A(Baseline and 6 hours)
- Lens Comfort - Filcon II 3 and Etafilcon A(Baseline, 3 hours, 6 hours)
- Lens Dryness - Filcon II 3 and Nelfilcon A(3 hours and 6 hours)
- Lens Handling - Filcon II 3 and Nelfilcon A(Baseline visit)
- Lens Handling (Removal) - Filcon II 3 and Nelfilcon A(6 hours)
- Lens Wettability - Filcon II 3 and Etafilcon A(Baseline and 6 hours)
- Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A(Baseline and 6 hours)
- Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A(6 hours)
- Lens Handling (Removal) - Filcon II 3 and Etafilcon A(6 hours)
- Lens Fit, Centration - Filcon II 3 and Etafilcon A(6 hours)
- Lens Fit, Centration - Filcon II 3 and Nelfilcon A(After 6 hours)
- Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A(Baseline and 6 hours)
- High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A(Baseline and 6 hours)
- Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A(6 hours)
- Lens Wettability - Filcon II 3 and Nelfilcon A(Baseline and 6 hours)
- Lens Fit, Tightness - Filcon II 3 and Nelfilcon A(Baseline and 6 hours)
- Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A(Baseline and 6 hours)
- Lens Fit, Centration - Filcon II 3 and Etafilcon A(Baseline)
- Lens Fit, Centration - Filcon II 3 and Nelfilcon A(Baseline)