Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
研究概览
简要总结
Open label, 1-week daily disposable, dispensing study
详细描述
Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between 18 and 40 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
- •Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
- •Has a spectacle cylinder up to 0.75D 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
- •Is not a habitual wearer of Avaira sphere lenses
- •Has a CL 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 2-4) 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
filcon IV 1 and ocufilcon D
Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.
干预措施: filcon IV 1 (Device)
filcon IV 1 and ocufilcon D
Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.
干预措施: ocufilcon D (Device)
结局指标
主要结局
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
时间窗: Baseline and 1 Week
Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
时间窗: Baseline and 1 Week
Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
时间窗: Baseline and 1 Week
Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
时间窗: Baseline and 1 Week
Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.
次要结局
- Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Visual Acuity - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D(1 Week)
- Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)
- Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D(Baseline and 1 Week)