Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 8
- 主要终点
- Overall Dryness
研究概览
简要总结
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
详细描述
The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.
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)
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
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 and 40 years of age (inclusive)
- •Has read, understood and signed the information consent letter
- •Has had a self-reported eye exam in the last two years
- •Is a spherical soft contact lens wearer
- •Has a contact lens prescription that fits within the available parameters of the study lenses
- •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
- •Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
- •Is willing and able to follow instructions and maintain the appointment 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 (defined as 5 days per week; >8 hours/day)
- •Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
- •Is habitually using rewetting/ lubricating eye drops more than once per 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
研究组 & 干预措施
fanfilcon A
Participants are randomized to wear fanfilcon A for two weeks during the cross over study.
干预措施: fanfilcon A (Device)
senofilcon A
Participants are randomized to wear senofilcon A for two weeks during the cross over study.
干预措施: senofilcon A (Device)
结局指标
主要结局
Overall Dryness
时间窗: 2 weeks
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Conjunctival Staining
时间窗: 2 weeks
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe
Vision Quality
时间窗: 2 weeks
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Lens Handling
时间窗: 2 weeks
Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Overall Comfort
时间窗: 2 weeks
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Smoothness
时间窗: 2 weeks
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Lens Centration
时间窗: 2 weeks
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Lens Hydrated
时间窗: 2 weeks
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Vision Satisfaction
时间窗: 2 weeks
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Clean Feeling
时间窗: 2 weeks
Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Lens Wettability
时间窗: 2 weeks
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
次要结局
未报告次要终点