NCT00762788已完成不适用
Clinical Trial of Several Contact Lenses in Extended Wear
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Incidence of Corneal Infiltrative Events
研究概览
简要总结
The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be of legal age, and be between 18 and 39 years of age.
- •Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- •Require a visual correction in both eyes (Monovision not allowed)
- •Require a soft contact lens spherical correction between -0.50 and -9.00D.
- •Have an astigmatic correction less than 1.50D in both eyes.
- •Be able to wear the lens powers available for this study.
- •Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
- •Be correctable to a visual acuity of 20/30 or better in each eye.
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection.
- •No clinically significant slit lamp findings
- •No other active ocular disease.
- •No previous ocular surgery.
排除标准
- •Requires concurrent ocular medication.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •PMMA or RGP lens wear in the previous 8 weeks.
- •Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment 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 enrollment only.
- •Participation in any concurrent clinical trial.
- •Currently wearing B&L PureVision, Ciba O2 Optix, Ciba Night & Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
- •Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
- •Has had an eye injury or surgery within the last eight weeks.
研究组 & 干预措施
senofilcon A contact lens
Active Comparator
ACUVUE OASYS
干预措施: senofilcon A (Device)
lotrafilcon A contact lens
Active Comparator
NIGHT&DAY
干预措施: lotrafilcon A (Device)
lotrafilcon B contact lens
Active Comparator
O2Optix
干预措施: lotrafilcon B (Device)
balafilcon A contact lens
Active Comparator
PureVision
干预措施: balafilcon A (Device)
comfilcon A contact lens
Active Comparator
Biofinity
干预措施: comfilcon A (Device)
etafilcon A contact lens
Active Comparator
ACUVUE 2
干预措施: etafilcon A (Device)
结局指标
主要结局
Incidence of Corneal Infiltrative Events
时间窗: 52 weeks
Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
Incidence of Adverse Events
时间窗: 52 weeks
Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.
次要结局
未报告次要终点
研究者
研究点 (1)
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