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临床试验/NCT00636194
NCT00636194已完成不适用

Product Performance of Bausch & Lomb Multi-Purpose Solution Compared to Alcon Opti-Free Replenish Multi-Purpose Solution When Used With Silicone Hydrogel Contact Lenses Worn on a Daily Wear Basis

Bausch & Lomb Incorporated1 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2008年2月1日最近更新:
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
361
试验地点
1
主要终点
Subjective Assessment of Comfort and Cleanliness

研究概览

简要总结

To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •Subjects are adapted wearers of silicone hydrogel contact lenses
  • •VA correctable to 0.3 LogMAR or better (driving vision)
  • •Clear central cornea
  • •Subject uses a lens care system on a regular basis

排除标准

  • •Systemic disease affecting ocular health
  • •Using systemic or topical medications
  • •wear a monovision, multifocal or toric contact lenses
  • •Any grade 2 or greater slit lamp findings

研究组 & 干预措施

B&L Multipurpose solution

Experimental

Bausch & Lomb Multipurpose Contact Lens Solution

干预措施: Bausch & Lomb Multipurpose Solution (Device)

Alcon Multipurpose Solution

Active Comparator

Alcon OptiFree Replenish Multipurpose Contact Lens Solution

干预措施: Alcon OptiFree Replenish Multipurpose Solution (Device)

结局指标

主要结局

Subjective Assessment of Comfort and Cleanliness

时间窗: 7 days

Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.

次要结局

  • Graded Slit Lamp Findings > Grade 2(2 week follow-up visit)
  • Symptoms and Complaints(2 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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