Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Lens Tightness on Push-up
研究概览
简要总结
The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.
详细描述
This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.
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
- •Has had a self-reported visual exam in the last two years
- •Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
- •Has a contact lens spherical prescription between -1.00 to - 6.00
- •Has a spectacle cylinder up to 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.
- •Patient contact lens refraction should fit 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:
- •Is not a habitual wearer of enfilcon A lenses
- •Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
- •Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- •Presence of clinically significant (grade 3-4) anterior segment abnormalities
- •Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •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 (past or present)
- •Seborrheic eczema, 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.
研究组 & 干预措施
enfilcon A (habitual)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
fanfilcon A (test)
Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.
干预措施: fanfilcon A (test) (Device)
结局指标
主要结局
Lens Tightness on Push-up
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.
Lens Fit - Centration
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.
Lens Fit - Post-blink Movement
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.
Overall Fit Acceptance
时间窗: Baseline, 1 week, 2 weeks, and 4 weeks
Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.
次要结局
- Overall Vision Satisfaction(Baseline, 1 week, 2 weeks, and 4 weeks)
- Dryness Overall(Baseline, 1 week, 2 weeks, and 4 weeks)
- Overall Satisfaction(Baseline, 1 week, 2 weeks, and 4 weeks)
- Wearing Times(Baseline, 1 week, 2 weeks, and 4 weeks)
- Conjunctival Staining(Baseline, 1 week, 2 weeks, and 4 weeks)
- Handling(Baseline, 1 week, 2 weeks, and 4 weeks)
- Lens Preference Overall(1 week, 2 weeks, and 4 weeks)
- Overall Comfort(Baseline, 1 week, 2 weeks, and 4 weeks)
- Corneal Staining(Baseline, 1 week, 2 weeks, and 4 weeks)