DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants With Corrected Visual Acuity of 0.0 or Better
研究概览
简要总结
The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared 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
- Single Group
- 主要目的
- Treatment
- 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
- •Be of legal age of consent and sign Informed Consent document.
- •Willing and able to wear spherical contact lenses for 16 hours.
- •Willing and able to wear spherical contact lenses within the available range of powers.
- •Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Anterior segment infection, inflammation, or abnormality.
- •Any use of systemic medications for which contact lens wear could be contraindicated.
- •History of refractive surgery or irregular cornea.
- •Currently enrolled in any clinical trial.
- •Eye injury within twelve weeks prior to enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Number of Participants With Corrected Visual Acuity of 0.0 or Better
时间窗: Up to 16 hours after lens insertion
Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.
Pre-Lens Noninvasive Tear Break-Up Time
时间窗: Up to 16 hours after lens insertion
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.
Average Tear Meniscus Height
时间窗: Up to 16 hours after lens insertion
The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.
Average Ocular Surface Temperature
时间窗: Up to 16 hours after lens insertion
Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.
次要结局
- Subjective Comfort(Up to 16 hours after lens insertion)
- Subjective Vision(Up to 16 hours after lens insertion)
- Number of Participants With Adequate Lens Fit(Up to 16 hours after lens insertion)