Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Participant's subjective rating of comfort, Questionnaire
研究概览
简要总结
A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design
详细描述
The objectives of the study are
- to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
- to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.
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)
盲法说明
This will be a double-masked study, with both the study participants and study investigators being masked to the order of lens wear for the initial and modified DD lens design. Study lenses will be dispensed to the participants at V2 and V4 by unmasked research assistants from paper cups. Lenses and blister-pack solution will be directly transferred into the paper cups, and only the paper cups will be taken to the examination room where lenses are being dispensed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 18 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 of Caucasian heritage;
- •Habitually wears soft spherical daily disposable contact lenses with a power between
- •0.50 to -2.75D (inclusive);
- •Demonstrates an acceptable fit with both study CL designs (initial & modified);
- •Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
- •Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
- •Should own a wearable pair of spectacles. -
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; -
结局指标
主要结局
Participant's subjective rating of comfort, Questionnaire
时间窗: 2 Days
Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses)
Participant's subjective rating of vision, Questionnaire
时间窗: 2 Days
Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear
Participant's subjective rating of lens handling, Questionnaire
时间窗: 2 Days
Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy
次要结局
未报告次要终点