NCT03496701已完成不适用
Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 8
- 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)
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)
次要结局
- Lens Centration(1 week on each study lenses)
- Post-blink Movement(1 week on each study lenses)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral LensesScleral Lens WearersNCT02643095Jennifer Fogt22
已完成
不适用
Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon AMyopiaNCT03226353Coopervision, Inc.77
已完成
不适用
Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens DesignPresbyopiaNCT04952701Coopervision, Inc.63
已完成
不适用
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of WearMyopiaNCT03974802Coopervision, Inc.41
已完成
不适用
Clinical Evaluation of Stenfilcon A Contact LensesMyopiaNCT03471832Coopervision, Inc.40