Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Dryness
研究概览
简要总结
Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
详细描述
The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.
The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.
Study groups:
Group 1: stenfilcon A vs. narafilcon A
Group 2: stenfilcon A vs. delefilcon A
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •A person is eligible for inclusion in the study if he/she:
- •Is over 18 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
- •Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
- •Can achieve a distance visual acuity of 20/30 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.
- •Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
- •Is willing to comply with the wear schedule.
- •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 daily disposable non-silicone hydrogel spherical contact lenses
- •Has a CL 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 CL wear (5 days per week; > 8 hours/day)
- •Has contact lens best corrected distance vision worse than 20/25 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
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Has aphakia, keratoconus or a highly irregular cornea.
- •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
stenfilcon A vs narafilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
干预措施: stenfilcon A (Device)
stenfilcon A vs narafilcon A (Group 1)
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
干预措施: narafilcon A (Device)
stenfilcon A vs delefilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
干预措施: stenfilcon A (Device)
stenfilcon A vs delefilcon A (Group 2)
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.
干预措施: delefilcon A (Device)
结局指标
主要结局
Dryness
时间窗: 1 week
Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Comfort
时间窗: 1 week
Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Vision
时间窗: 1 week
Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Handling
时间窗: 1 week
Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
时间窗: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
时间窗: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).
Pain and Foreign Body Sensation
时间窗: 1 week
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Itching Sensation on Removal
时间窗: 1 week
Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Red Eye Sensation
时间窗: 1 week
Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
次要结局
- Lens Fit - Horizontal Centration(1 week)
- Conjunctival Redness(1 week)
- Lens Fit - Vertical Centration(1 week)
- Lens Fit - Post-blink Movement(1 week)
- Lens Fit Overall(1 week)
- Limbal Redness(1 week)
- Corneal Staining(1 week)
- Corneal Neovascularization(1 week)
- Conjunctival Staining(1 week)
- Corneal Oedema(1 week)
- Papillary Conjunctivitis(1 week)
- Lens Fit - Horizontal Centration(Baseline)
- Lens Fit - Vertical Centration(Baseline)
- Lens Fit - Post-blink Movement(Baseline)
- Lens Fit Overall(Baseline)