Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees
研究概览
简要总结
The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Have no active ocular disease or allergic conjunctivitis.
- •Not be using any topical ocular medications.
- •Be willing and able to follow instructions.
- •Have signed a statement of informed consent.
排除标准
- •Participating in a conflicting study.
- •Considered by the Investigator to not be a suitable candidate for participation.
结局指标
主要结局
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees
时间窗: 3 minutes
Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant.
次要结局
未报告次要终点