Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Fit Acceptability
研究概览
简要总结
This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study
详细描述
The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.
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
- Treatment
- 盲法
- Single (Participant)
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 had a self-reported eye exam in the last two years
- •Is a habitual soft toric lens wearer
- •Can be successfully fit with study lenses (≥ grade 2 fit acceptance)
- •Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)
- •Has a spectacle cylinder of at least 0.75D in each eye.
- •Can achieve best corrected spectacle refraction 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
- •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 frequently using rewetting/ lubricating eye drops (more than once per day)
研究组 & 干预措施
enfilcon A (habitual)
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
fanfilcon A
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
干预措施: fanfilcon A (Device)
结局指标
主要结局
Fit Acceptability
时间窗: baseline, 2 weeks, 1 month
Investigator fit acceptability for each lens pair. 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)
Visual Acuity
时间窗: baseline, 2 weeks, 1 month
High contrast distance visual acuity is measured by LogMAR.
Post-blink Movement
时间窗: baseline, 2 weeks, 1 month
Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Centration
时间窗: baseline, 2 weeks, 1 month
Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Corneal Coverage
时间窗: baseline, 2 weeks, 1 month
Corneal coverage will be assessed (yes/no)
次要结局
未报告次要终点