Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 12
- 主要终点
- Corneal Infiltrates - Enfilcon A Lens (Control)
研究概览
简要总结
This study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control).
详细描述
Subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon A lens (test) to enfilcon A lens (control). This should result in a study population of approximately 60 test subjects and 30 control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age as of the date of evaluation for the study.
- •Read the Informed Consent
- •Been given an explanation of the Informed Consent
- •Indicated understanding of the Informed Consent
- •Signed the Informed Consent document.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study.
- •Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
- •Be in good general health, based on his/her knowledge.
- •Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
- •Have manifest refraction Snellen visual acuities (VA) equal to or better than20/25 in each eye.
- •To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal.
排除标准
- •Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. Note: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- •Poor personal hygiene.
- •Any active participation in another clinical trial during this trial or within 30 days prior to this study.
- •To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months.
- •A member, relative or household member of the investigator or of the investigational office staff.
- •Has a known sensitivity to the ingredients used in the Multi-Purpose Disinfection Lens Care System (MPS) approved for use in the study and is unable or unwilling to use the alternate care system.
- •Previous refractive surgery; or current or previous orthokeratology treatment.
- •Is aphakic or pseudophakic.
- •Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes.
- •The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day.
- •The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections.
- •A history of papillary conjunctivitis that has interfered with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- •Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
- •Pterygium
- •Corneal scars within the visual axis
- •Neovascularization or ghost vessels > 1.0 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) of > Grade 2
- •Anterior uveitis or iritis
- •Seborrheic eczema, seborrheic conjunctivitis or blepharitis
研究组 & 干预措施
fanfilcon A (test)
Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.
干预措施: fanfilcon A (test) (Device)
enfilcon A (control)
Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.
干预措施: enfilcon A (control) (Device)
结局指标
主要结局
Corneal Infiltrates - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present
Stromal Edema - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Stromal Edema - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Corneal Staining - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Epithelial Edema - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Corneal Infiltrates - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Corneal Vascularization - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Limbal Hyperemia - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Bulbar Hyperemia - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Bulbar Hyperemia - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Visual Acuity - Fanfilcon A Lens (Test)
时间窗: Week 1, Week 2, Month 1, Month 2, Month 3
Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.
Visual Acuity - Enfilcon A Lens (Control)
时间窗: Week 1, Week 2, Month 1, Month 2, Month 3
Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.
Average Wearing Time - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Average lens wearing time for enfilcon A lens (control) measured in hours.
Epithelial Edema - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Limbal Hyperemia - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Palpebral Conjunctiva - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present
Palpebral Conjunctiva - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present
Corneal Vascularization - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Corneal Staining - Enfilcon A Lens (Control)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;
Average Wearing Time - Fanfilcon A Lens (Test)
时间窗: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Average lens wearing time for fanfilcon A lens (test) measured in hours.
次要结局
- Ease of Insertion and Removal - Fanfilcon A Lens (Test)(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)
- Comfort - Fanfilcon A Lens (Test)(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)
- Comfort - Enfilcon A Lens (Control)(Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up)
- Ease of Insertion and Removal - Enfilcon A Lens (Control)(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)
- Overall Vision Quality - Fanfilcon A Lens (Test)(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)
- Overall Vision Quality - Enfilcon A Lens (Control)(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)