Performance Comparison Between Comfilcon A and Senofilcon C Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 5
- 主要终点
- Lens Lag at Primary Gaze
研究概览
简要总结
The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.
详细描述
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.
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 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 a spherical soft contact lens wearer
- •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 prescription that fits within the available parameters of the study lenses.
- •Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 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 (defined as 6 days per week; > 10 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
- •Is currently wearing daily disposable lenses
研究组 & 干预措施
comfilcon A
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
干预措施: comfilcon A (Device)
senofilcon C
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
干预措施: senofilcon C (Device)
结局指标
主要结局
Lens Lag at Primary Gaze
时间窗: Up to 1 month
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Post-blink Movement
时间窗: Up to 1 month
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Corneal Coverage
时间窗: Up to 1 month
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Lens Centration
时间窗: Up to 1 month
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Lens Wettability
时间窗: Up to 1 month
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Deposit Grading
时间窗: Up to 1 month
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Overall Lens Fit Acceptance
时间窗: Up to 1 month
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Tightness on Push up
时间窗: Up to 1 month
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
次要结局
未报告次要终点