Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- HRT Corneal Scan
研究概览
简要总结
Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.
详细描述
Several types of solutions are used in contact lens wear.
Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.
The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Vision correctable to 20/30 or better in both eyes
- •Successful soft contact lens wear for at least 2 weeks prior to enrollment
排除标准
- •History of hypersensitivity to any of the components in any of the lens solutions
- •One functional eye or a monofit lens
- •Any abnormal slit-lamp finding at baseline
- •Use of topical ocular meds
- •Any systemic condition with significant ocular side effects or that interfere with contact lens wear
- •Enrollment of the investigator's office staff, relatives or members of their respective households
- •Enrollment of more than one member of the same household
研究组 & 干预措施
Placebo 1
Subjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contact lenses were removed. An HRT was performed immediately after removing the contact lenses. The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
干预措施: Clear Care (Drug)
Renu
Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours. After 10 hours of the lenses soaking in ReNu the subject returned. The contacts were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contacts lenses were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
干预措施: ReNu (Drug)
Optifree
Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours. After 10 hours of the lenses soaking in Optifree Replenish the subject returned. The contacts were inserted onto the patients eyes. The patient wore contacts the for two hours. After two hours the contacts were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
干预措施: OPTI-FREE (Drug)
结局指标
主要结局
HRT Corneal Scan
时间窗: baseline and 2 hours
Looking for cell density
次要结局
未报告次要终点
研究者
Christine Sindt
Principal Investigator
University of Iowa