A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 365
- 主要终点
- Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
研究概览
简要总结
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.
排除标准
- •Wearing monovision lenses
- •Have had refractive surgery within the previous 12 months
- •Have infection of the eye, eyelids or eye structures.
研究组 & 干预措施
Carboxymethylcellulose Based Eye Drop Formula
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
干预措施: carboxymethylcellulose based eye drop formula (Drug)
REFRESH CONTACTS®
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
干预措施: carboxymethylcellulose sodium based eye drop solution (Drug)
结局指标
主要结局
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
时间窗: Baseline, Day 90
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
次要结局
未报告次要终点