Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 9
- 主要终点
- Ex Vivo Total Cholesterol Uptake at Day 30
研究概览
简要总结
The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.
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
- •Must sign informed consent document;
- •Vision correctable to 0.1 (LogMAR) or better in each eye at distance with habitual lenses;
- •Manifest cylinder (at screening) less than or equal to 0.75 diopter (D) in each eye and spectacle add <+0.50 D in each eye;
- •Current full-time wearer of spherical samfilcon A, comfilcon A, senofilcon C monthly or senofilcon A 2-week replacement lens within the power range of lens powers available;
- •Current user of an MPS (excluding OFPM) to care for lenses;
- •Willing to answer text messages on a daily basis during the study;
- •Willing to discontinue artificial tears during the study and rewetting drops on the days of study visits;
- •Use of digital devices (eg, smart phone, tablet, laptop or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue for the duration of the study;
- •Other protocol specific inclusion criteria may apply.
排除标准
- •Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 or more nights per week);
- •Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear;
- •History of herpetic keratitis, corneal surgery or irregular cornea;
- •Prior refractive surgery;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- •Currently using or have not discontinued Restasis®, Xiidra™ and/or topical steroids within the past 7 days;
- •Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Known pregnancy or lactating;
- •Other protocol specific exclusion criteria may apply.
研究组 & 干预措施
AOHG
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
干预措施: Lotrafilcon B contact lenses with added wetting agent (Device)
AOHG
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
干预措施: POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent (Device)
AOHG
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized
干预措施: Hydrogen peroxide-based contact lens solution with added wetting agent (Device)
Habitual
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
干预措施: Samfilcon A contact lenses (Device)
Habitual
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
干预措施: Senofilcon C contact lenses (Device)
Habitual
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
干预措施: Senofilcon A contact lenses (Device)
Habitual
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
干预措施: Comfilcon A contact lenses (Device)
Habitual
Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS)
干预措施: Habitual Multi-Purpose Solution (HMPS) (Device)
结局指标
主要结局
Ex Vivo Total Cholesterol Uptake at Day 30
时间窗: Day 30
The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.
次要结局
未报告次要终点