Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Overall Fit Acceptance
研究概览
简要总结
This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the investigator and the subjects are masked to the identity of the study lenses. Lenses were over-labelled and coded to mask the lens foil. Over-labelling was carried out by the study sponsor following specific SOPs (see ICH GCP guidelines Section 5.13).
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read and sign the Informed Consent form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Healthy adult males or females aged 18-55 years.
- •The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
- •The subject's refractive cylinder must be ≤1.00 D in each eye.
- •The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
- •The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating
- •Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Extended wear contact lens correction.
- •Any current use of ocular medication.
- •Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- •Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
- •Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
- •Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
研究组 & 干预措施
C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Test 8.5BC (Device)
C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Test 9.0BC (Device)
C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Control 8.5BC (Device)
C 8.5\C 9.0\T 8.5\T 9.0
Subjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Control 9.0BC (Device)
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Test 8.5BC (Device)
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Test 9.0BC (Device)
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Control 8.5BC (Device)
C 9.0\C 8.5\T 9.0\T 8.5
Subjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Control 9.0BC (Device)
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Test 8.5BC (Device)
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Test 9.0BC (Device)
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Control 8.5BC (Device)
T 8.5\T 9.0\C 8.5\C 9.0
Subjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
干预措施: Control 9.0BC (Device)
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Test 8.5BC (Device)
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Test 9.0BC (Device)
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Control 8.5BC (Device)
T 9.0\T 8.5\C 9.0\C 8.5
Subjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
干预措施: Control 9.0BC (Device)
结局指标
主要结局
Overall Fit Acceptance
时间窗: 30-45 minutes after lens settling
Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.
Lens Power Requirement
时间窗: 30-45 minutes after lens settling
The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).
次要结局
- Subjective Comfort at Lens Insertion(Immediately upon lens insertion)
- Subjective Comfort After Lens Settling(30-45 minutes after lens settling)
- Subjective Vision Quality(30-45 minutes after lens settling)
- Subjective Handling(Immediately upon lens insertion)
- Monocular High Contrast Visual Acuity (VA)(30-45 minutes after lens settling)