Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subjective Ratings of Lens Handling for Removal Per Intervention
研究概览
简要总结
The initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and Investigators will be masked to which lens type (brand) the participants will be wearing in each eye during the study.
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
- •Is between 18 and 40 years of age inclusively 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 a neophyte who has no history of any previous contact lens handling experience;
- •Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);
- •Has visual acuity ≤0.20 logMAR each eye with study lenses;
- •Demonstrates acceptable fit with study lenses;
- •Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye);
- •Is willing to wear study CLs at least 5 days per week and 6 hours per day throughout the study
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 self-report);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has taken part in another clinical research study within the last 14 days;
- •Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.
- •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.
研究组 & 干预措施
Etafilcon A / Verofilcon A
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
干预措施: Verafilcon A (Device)
Verofilcon A / Etafilcon A
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
干预措施: Verafilcon A (Device)
Verofilcon A / Etafilcon A
The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.
干预措施: Etafilcon A (Device)
Etafilcon A / Verofilcon A
The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.
干预措施: Etafilcon A (Device)
结局指标
主要结局
Subjective Ratings of Lens Handling for Removal Per Intervention
时间窗: Baseline
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for removal on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to remove.
Subjective Ratings of Lens Handling for Insertion Per Intervention
时间窗: Baseline
At the initial visit, once participants had successfully completed contact lens insertion and removal training, participants were asked to rate the subjective handling of the lens for insertion on a scale from 0 (worst) to 100 (best) using a visual analog scale per intervention. Higher scores indicate that the lens was very easy to insert.
次要结局
未报告次要终点