A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 180
- 主要终点
- Tear Break-Up Time (TBUT) in the Study Eye
研究概览
简要总结
This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.
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
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of age-related cataract in the study eye
- •Scheduled for cataract surgery and lens implant
排除标准
- •Diagnosis of ocular surface disease or glaucoma
- •Ocular surgery in the past 3 months
- •Wearing a corneal contact lens in the study eye
研究组 & 干预措施
Sodium Carboxymethylcellulose and Conventional Therapy
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
干预措施: Sodium Carboxymethylcellulose (Drug)
Sodium Carboxymethylcellulose and Conventional Therapy
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
干预措施: Levofloxacin (Drug)
Sodium Carboxymethylcellulose and Conventional Therapy
Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
干预措施: Prednisolone (Drug)
Conventional Therapy
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
干预措施: Levofloxacin (Drug)
Conventional Therapy
Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Tear Break-Up Time (TBUT) in the Study Eye
时间窗: Day 30
TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.
次要结局
- Fluorescein Staining Score in the Study Eye(Day 7, Day 30)
- Lissamine Green Staining Score in the Study Eye(Day 7, Day 30)
- Results of Schirmer I Test With Anesthetics in the Study Eye(Day 7, Day 30)
- Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye(Day 7, Day 30)
- Subjective Symptom Total Score in the Study Eye(Day 7, Day 30)