Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
研究概览
简要总结
The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal eyes with no use of ocular medications.
- •Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- •Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
- •Visual acuity with study lenses 20/25 or better.
- •Cylinder less than or equal to 0.75 D.
- •Currently wearing daily disposable lenses.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Anterior segment infection, inflammation, or abnormality.
- •Any active anterior segment ocular disease that would contraindicate contact lens wear.
- •Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- •History of refractive surgery or irregular cornea.
- •Eye injury within twelve weeks immediately prior to enrollment for this trial.
- •Currently enrolled in any clinical trial.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
时间窗: 1 week of wear, replacing lenses daily
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Overall Vision Quality
时间窗: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
时间窗: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
时间窗: 1 week of wear, replacing lenses daily
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
次要结局
- Overall Lens Fit(1 week of wear, replacing lenses daily)