Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
研究概览
简要总结
Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®
详细描述
The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 soft spherical contact lens wearer
- •Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
- •Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
- •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
- •Is willing to comply with the visit schedule
排除标准
- •Is not a habitual wearer of soft spherical contact lenses
- •Has a contact lens prescription outside the range of the available parameters of the study lenses
- •Has a contact lens prescription outside the range of the inclusion power range
- •Has a spectacle cylinder ≥1.00D of cylinder in either eye
- •Has a history of not achieving comfortable contact lens 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) 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:
- •Moderate to severe dry eye
- •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
结局指标
主要结局
Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)
Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)
Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)
Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior
Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior
Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.
Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)
Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)
Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A
时间窗: 6 hours
Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).
次要结局
- Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(6 hours)
- Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(6 hours)
- Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(Baseline, 3 hours, 6 hours)
- Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(Baseline)
- Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(6 hours)
- Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(Baseline, 3 hours, 6 hours)
- Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(Baseline and 6 hours)
- Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(Baseline, 3 hours, 6 hours)
- Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(6 hours)
- Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A(6 hours)