Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Mean Overall Comfort Given at End of Wear
研究概览
简要总结
The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.
详细描述
Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •17 years of age; full legal capacity to volunteer.
- •Ocular examination within the last two years
- •Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
- •Currently wearing soft contact lenses.
- •Clear corneas; no active ocular disease.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
- •Monovision.
- •Any ocular disease.
- •Never worn contact lenses before.
- •Corneal refractive surgery.
- •Uses topical ocular medicine.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Overall Comfort Given at End of Wear
时间窗: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Mean Value of Comfort During the Day
时间窗: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged.
Mean Overall Quality of Vision at End of Wear
时间窗: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day.
Mean Overall Ease of Handling at End of Wear
时间窗: Part 1: Day 3
The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day.
Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear
时间窗: Part 1: Day 2
The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day.
Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear
时间窗: Part 1: Day 3
The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day.
Lens Wettability
时间窗: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.
Percentage of Participants Responding "Yes"
时间窗: Part 2: Day 7
The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.
次要结局
未报告次要终点