Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
研究概览
简要总结
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.
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
- •Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
- •Symptoms of contact lens discomfort as defined by the protocol.
- •Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit
- •Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Extended (over-night) contact lens wearer.
- •Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- •Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
时间窗: Baseline (Day 0), Day 90
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse \& tufts papillae); 3 = Moderate (moderate \& tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
次要结局
- Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90(Day 90)
- Mean Frequency Score for Symptoms of Grittiness at Day 90(Day 90)
- Mean Frequency Score for Symptoms of Dryness at Day 90(Day 90)