AOSEPT™ PLUS With HydraGlyde FID 120947A and AOCup Lens Case (CLEAR CARE PLUS) and AOSEPT™ PLUS FID 119056 and AOCup Lens Case (CLEAR CARE) Family PMCF Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 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 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.
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 Institution Review Board 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) or rigid gas permeable (RGP) 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.
研究组 & 干预措施
AOSEPT Plus (CC)
AOSEPT Plus and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
干预措施: AOSEPT Plus and AOCup lens case (Device)
AOSEPT Plus (CC)
AOSEPT Plus and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
干预措施: Habitual contact lenses (Device)
AOSEPT Plus with HydraGlyde (CCP)
AOSEPT Plus with HydraGlyde and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
干预措施: AOSEPT Plus with HydraGlyde and AOCup lens case (Device)
AOSEPT Plus with HydraGlyde (CCP)
AOSEPT Plus with HydraGlyde and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.
干预措施: Habitual contact lenses (Device)
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