Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Comparison of Lens Fit Characteristics
研究概览
简要总结
The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact 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)
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
- •Be of legal age (i.e., at least 18 years old)
- •Sign a written informed consent
- •Have contact lens distance sphere requirement in the range -1.00D to -6.00D
- •Have spectacle astigmatism <1.25D in each eye
- •Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
- •Have normal eyes with no evidence of abnormality or disease.
排除标准
- •Required concurrent ocular medication
- •Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
- •Abnormal lacrimal secretions
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial
- •Known allergy to silver, silver ions, or silver containing compounds.
研究组 & 干预措施
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A Habitual Lens (Device)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A Habitual Lens (Device)
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A Habitual Lens (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A Habitual Lens (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A 8.7 BC (Investigational) (Device)
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
干预措施: Galyfilcon A 8.3 BC (Investigational) (Device)
结局指标
主要结局
Comparison of Lens Fit Characteristics
时间窗: Approximately 40 minutes of wear time
At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): * Visual Acuity (logMar) * Over-refraction with Visual Acuity * Fit acceptability (acceptable/non-acceptable)
Evaluation of Inter-Changeability
时间窗: Approximately 40 minutes of wear time
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)
Determination of fit or Vision Differences
时间窗: Approximately 40 minutes of wear time
In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: * Ease of handling of the lenses- by Investigator * Comfort on insertion After 30-40 minutes of settling time the following variables will be collected: * Subjective comfort after settling * Visual Acuity (logMar) * Corneal coverage (Y/N) * Post-blink movement (mm) * Version Lag (mm) * Tightness on push-up (0-100 scale) * Overall fit acceptance (0-5 scale)
次要结局
未报告次要终点