A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Up Gaze Lag Assessed Observing Lens Movement in Graticule
研究概览
简要总结
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).
详细描述
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
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
- •Is at least 18 years of age and has full legal capacity to volunteer
- •Has read, fully understood and signed the information consent letter
- •Currently wears or has previously worn soft contact lenses
- •Has spectacle cylinder ≤1.00D in both eyes.
- •Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
- •Has clear corneas and no active ocular disease
- •Is willing and able to follow product usage instructions and maintain the visit schedule.
排除标准
- •Has never worn contact lenses before
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- •Has any known active ocular disease and/or infection
- •Has a monovision correction
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
- •Is aphakic
- •Has undergone corneal refractive surgery
- •Is pregnant or lactating, determined by self-report
研究组 & 干预措施
Test lens
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
干预措施: Test Lens (Device)
Test lens
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
干预措施: Control Lens (Device)
nelfilcon A lens (control)
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
干预措施: Test Lens (Device)
nelfilcon A lens (control)
Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
干预措施: Control Lens (Device)
结局指标
主要结局
Up Gaze Lag Assessed Observing Lens Movement in Graticule
时间窗: 6 hours
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Lens Tightness Assessed by Push-up Test
时间窗: 6-hours
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
时间窗: 6 hours
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance
时间窗: 6 hours
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Vertical Lens Centration Assessed in Primary Gaze
时间窗: 6-hours
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
时间窗: 6 hours
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
时间窗: 6 hours
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Horizontal Lens Centration Assessed in Primary Gaze
时间窗: 6-hour
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Horizontal Lens Centration Assessed in Primary Gaze
时间窗: Baseline
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)
Vertical Lens Centration Assessed in Primary Gaze
时间窗: Baseline
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Lens Tightness Assessed by Push-up Test
时间窗: Baseline
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
时间窗: Baseline
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
时间窗: Baseline
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance
时间窗: Baseline
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Up Gaze Lag Assessed Observing Lens Movement in Graticule
时间窗: Baseline
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
时间窗: Baseline
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
次要结局
未报告次要终点