One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Lens Fit - Centration
研究概览
简要总结
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
详细描述
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 and 34 years of age (inclusive)
- •Has had a self-reported eye exam in the last two years
- •Is an adapted comfilcon A sphere contact lens wearer
- •Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
- •Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
- •Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
- •Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- •Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter.
- •Has a contact lens refraction that fits within the available parameters of the study lenses.
- •Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- •Is willing to comply with the visit schedule
排除标准
- •A person will be excluded from the study if he/she:
- •Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
- •Presents with clinically significant anterior segment abnormalities
- •Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
- •Presents with slit lamp findings 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 aphakia, keratoconus or a highly irregular cornea.
- •Has presbyopia or has dependence on spectacles for near work over the contact lenses.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
- •Is habitually using rewetting/ lubricating eye drops (more than once per day)
研究组 & 干预措施
comfilcon A asphere (test)
Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
干预措施: comfilcon A asphere lens (test) (Device)
comfilcon A sphere (control)
Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
干预措施: comfilcon A sphere lens (control) (Device)
结局指标
主要结局
Lens Fit - Centration
时间窗: baseline, 2 weeks, 1 month
Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Lens Fit - Post-blink Movement
时间窗: baseline, 2 weeks, 1 month
Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Preference/Acceptability
时间窗: baseline, 2 weeks, 1 month
Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).
Lens Fit - Corneal Coverage
时间窗: baseline, 2 weeks, 1 month
Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).
次要结局
未报告次要终点