One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
研究概览
简要总结
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
详细描述
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Must sign Informed Consent Document;
- •Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
- •Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
- •Willing to answer text messages on a daily basis during the study;
- •Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
- •Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- •History of herpetic keratitis, corneal surgery or irregular cornea;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Pregnant or lactating;
- •Participation in any clinical study within 30 days of Visit 1;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Lotrafilcon B contact lenses with EOBO-41 (Device)
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Lotrafilcon B contact lenses (Device)
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Hydrogen peroxide-based lens care solution (Device)
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Saline solution for rinsing contact lenses (Device)
AOHG, then AOA
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Saline solution for rinsing contact lens case (Device)
AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Lotrafilcon B contact lenses with EOBO-41 (Device)
AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Lotrafilcon B contact lenses (Device)
AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Hydrogen peroxide-based lens care solution (Device)
AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Saline solution for rinsing contact lenses (Device)
AOA, then AOHG
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
干预措施: Saline solution for rinsing contact lens case (Device)
结局指标
主要结局
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
时间窗: Day 30, each product
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
次要结局
- Change From Insertion in Minimum Protected Area (MPA)(Hour 0 (Lens Insertion) to Hour 12 on Day 1)
- Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear(Day 30, each product)