EVALUATION OF THE EFFECTS OF CLEAR CARE® / AOSEPT® PLUS HYDROGEN PEROXIDE SOLUTION ON THE EYELID TISSUES - Part III: COMPARATIVE EVALUATION WITH RENU® MPS OVER 3 MONTH OF WEAR - CONTROL EVALUATION WITH AIR OPTIX® AQUA and ACUVUE® 2®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Maximum Papillae
研究概览
简要总结
The purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one PHMB containing multipurpose system) with ACUVUE® 2® and AIR OPTIX® AQUA contact lenses worn on a daily wear basis for a 3-month period.
详细描述
This study was divided into 2 periods, a Screening Phase and an Investigational Phase. During the Screening Phase, subjects were fitted and dispensed with either ACUVUE® 2® (for current hydrogel wearers) or AIR OPTIX® AQUA (for current silicone hydrogel wearers) contact lenses and used COMPLETE® MPS Easy Rub® Formula to clean and disinfect their lenses. At the completion of the Screening Phase, the symptomatic status of the subjects was re-assessed. Those subjects who qualified proceeded to the Investigational Phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the Screening Phase to use in conjunction with the allocated study care product, CLEAR CARE® /AOSEPT® Plus or ReNu MultiPlus®.
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
- Single (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
- •Read and understand the Participant Information Sheet;
- •Read, sign, and date an Informed Consent;
- •Successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality;
- •Classified as symptomatic according to protocol-specified criteria;
- •Agree to wear study contact lenses as directed for the duration of the study;
- •Best corrected visual acuity (BCVA) of 6/9 or better in each eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
- •Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
- •History of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study;
- •Systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects;
- •Ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study;
- •Active ocular infection;
- •Use of any concomitant topical ocular medications during the study period;
- •Significant ocular anomaly;
- •Previous ocular surgery;
- •History of recent, significant changes in visual acuity;
- •Any medical condition that might be prejudicial to the study;
- •Pregnant, planning to be become pregnant, or lactating at time of enrollment;
- •Any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. HIV), or diabetes;
- •Participation in an investigational drug or device study within 30 days of entering study;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Maximum Papillae
时间窗: Baseline (Day 0), Month 3
Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Maximum Eyelid Hyperaemia
时间窗: Baseline (Day 0), Month 3
Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Redness
时间窗: Baseline (Day 0), Month 3
The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
Mean Upper Eyelid Margin Staining
时间窗: Baseline (Day 0), Month 3
The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.
次要结局
- Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)(Month 3)