NCT01518868已完成不适用
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
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
- 126
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.
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
- •Have physiologically normal anterior segments
- •Be adapted wearers of soft contact lenses and wear a lens in each eye.
- •Be presbyopic and require near add correction in each eye.
- •Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
- •Have no active ocular disease or allergic conjunctivitis.
- •Must not be using any topical ocular medications.
- •Must habitually use a lens care product for lens cleaning, disinfecting, and storage.
排除标准
- •Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Anisometropia (spherical equivalent) of greater than 2.00 D.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Allergic to any component in the study products.
- •Ocular astigmatism of greater than 1.00 D in either eye.
- •Have had any corneal surgery (ie, refractive surgery).
- •Uses AMO Ultra Care as their habitual lens care regimen.
- •Is a toric contact lens wearer.
- •Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- •An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
研究组 & 干预措施
Investigational contact lens
Experimental
multifocal high add soft contact lens
干预措施: Investigational contact lens (Device)
PureVision contact lens
Active Comparator
Multi-focal contact lens
干预措施: PureVision contact lens (Device)
结局指标
主要结局
Visual Acuity
时间窗: At 2 weeks follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms/Complaints(At 2 weeks follow up)
研究者
研究点 (1)
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