OPTI-FREE Family (OPTI-FREE EXPRESS™, OPTI-FREE PureMoist™, OPTI-FREE REPLENISH™) PMCF STUDY
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Front surface deposits at Day 90
研究概览
简要总结
The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 3 commercially available contact lens cleaning and disinfecting solutions in a pediatric population. This study will be conducted in Canada and the US.
详细描述
Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and parent/legally authorized representative able to understand and sign an IRB approved informed consent/assent form.
- •Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
- •Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular disease or condition that would contraindicate contact lens wear.
- •Use of systemic or ocular medication that would contraindicate contact lens wear.
- •Any known sensitivity to any ingredients in the study products.
- •Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
- •Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Front surface deposits at Day 90
时间窗: Day 90
Protein and lipid deposits on the front surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Back surface deposits at Day 90
时间窗: Day 90
Protein and lipid deposits on the back surface of the contact lens will be assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits will be graded on a 5-point scale, with 0 being absent and 4 being severe.
Incidence of corneal infiltrative events
时间窗: Up to Day 90
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. Corneal infiltrative events will be detected by the investigator during an eye exam.
Incidence of microbial keratitis
时间窗: Up to Day 90
Microbial keratitis is a sight-threatening infection of the cornea. Incidences of microbial keratitis will be detected by the investigator during an eye exam.
Incidence of solution induced corneal staining (SICS)
时间窗: Up to Day 90
Corneal staining determined by the investigator to be solution-related will be graded by type (pattern of staining) and area (how much) in each of the 5 corneal regions: central, superior, nasal, inferior, temporal.
次要结局
未报告次要终点