Ocular Comfort and the "Aging" Lens (ERBIUM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
研究概览
简要总结
The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.
详细描述
Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.
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
- 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
- •At least 17 years of age.
- •Ocular exam in the last two years.
- •Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
- •Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
- •Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease.
- •Systemic condition that may affect a study outcome.
- •Using any systemic or topical medications that may affect ocular health.
- •Wears lenses on an extended or continuous wear schedule.
- •Habitually wears multifocal lenses.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
时间窗: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
时间窗: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
时间窗: Day 1
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
时间窗: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
时间窗: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
时间窗: Day 15
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
时间窗: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
时间窗: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
时间窗: Day 43
Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE ("I CANNOT tolerate the comfort of my eyes! I am in pain!")and 100=VERY COMFORTABLE \& FRESH ("Wow! My eyes feel incredible! I love this feeling.")
次要结局
未报告次要终点