Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Overall Lens Fit Acceptance
研究概览
简要总结
The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.
详细描述
This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（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 between 18 and 35 years of age (inclusive)
- •Has read and signed the informed consent letter
- •Is willing and anticipated to follow instructions and maintain the appointment schedule
- •Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
- •Habitually wears or is able to be adequately refit into MyDay Sphere lenses
- •Demonstrates an acceptable fit with the study lenses
- •Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
- •Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
- •Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
- •Has clear corneas and no active ocular disease
- •Has a contact lens refraction that fits within the available parameters of the study lenses.
排除标准
- •A person will be excluded from the study if he/she:
- •Is participating in any concurrent clinical research study
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has a systemic condition that, in the opinion of the investigator, may affect the study measures
- •Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
- •Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Significant pterygium, pinguecula, or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from of the limbus
- •Giant papillary conjunctivitis (GCP) worse than grade 1
- •Anterior uveitis or iritis (or history in past year)
- •Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- •History of corneal ulcers or fungal infections
- •Poor personal hygiene
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
- •Has aphakia, keratoconus or a highly irregular cornea.
- •Has presbyopia or has dependence on spectacles for near work over the contact lenses.
- •Has undergone refractive surgery.
- •Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
- •Has participated in any other type of eye related clinical or research study within the last 7 days
- •Is habitually using rewetting/ lubricating eye drops (more than once per day)
研究组 & 干预措施
Stenfilcon A / Test lens
All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.
干预措施: Test lens (Device)
Stenfilcon A / Test lens
All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.
干预措施: control lens (Device)
结局指标
主要结局
Overall Lens Fit Acceptance
时间窗: 1 week on each study lenses
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Overall Lens Fit Acceptance
时间窗: Baseline (After 10 minutes of lens dispense)
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
次要结局
- Post-blink Movement(1 week on each study lenses)
- Lens Centration(1 week on each study lenses)
- Lens Centration(Baseline - After 10 minutes of lens dispense)
- Post-blink Movement(Baseline (after 10 minutes of lens dispense))