Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Overall Comfort
研究概览
简要总结
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
详细描述
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Has had an oculo-visual examination in the last two years
- •Is at least 18 years of age and has full legal capacity to volunteer
- •Has read and understood the information consent letter
- •Is willing and able to follow instructions and maintain the appointment schedule
- •Is correctable to a visual acuity of 20/50 or better (in at least one eye)
- •Currently wears soft toric contact lenses in both eyes
- •Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
- •-20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
- •+8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
- •-20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
- •-6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
- •+6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
- •Has clear corneas and no active ocular disease
- •Demonstrates an acceptable fit with the study lenses
排除标准
- •Has never worn contact lenses before;
- •Has any systemic disease affecting ocular health;
- •Is using any systemic or topical medications that will affect ocular health;
- •Has any ocular pathology or abnormality that would affect the wearing of 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
comfilcon A toric
Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
干预措施: comfilcon A Toric (Device)
结局指标
主要结局
Overall Comfort
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
Overall Vision
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
Lens Fit - Overall Stability
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
Anterior Ocular Health - Palpebral Hyperemia and Roughness
时间窗: Baseline and 2 weeks
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
Anterior Ocular Health - Conjunctival Staining and Indentation
时间窗: Baseline and 2 weeks
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
Anterior Ocular Health - Corneal Staining
时间窗: Baseline and 2 weeks
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= \>45% of area
Visual Acuity
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
Subjective Preference - Comfort
时间窗: Baseline and 2 weeks
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Handling
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
Overall Satisfaction
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
Anterior Ocular Health - Bulbar and Limbal Redness
时间窗: Baseline and 2 weeks
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
Lens Fit - Rotation
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
Lens Fit Acceptance
时间窗: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
Preference - Vision
时间窗: Baseline and 2 weeks
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Preference - Handling
时间窗: Baseline and 2 weeks
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Overall Preference
时间窗: Baseline and 2 weeks
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Investigator Acceptability
时间窗: Baseline and 2 weeks
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
次要结局
未报告次要终点