Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 315
- 主要终点
- Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
研究概览
简要总结
This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Current use of eye drops for dry eye at least twice daily, on average for at least 3 months
排除标准
- •Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
- •Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
- •Active ocular allergy
研究组 & 干预措施
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
干预措施: Carboxymethylcellulose Based Eye Drop Formulation A (Drug)
Carboxymethylcellulose Based Eye Drop Formulation B
Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
干预措施: Carboxymethylcellulose Based Eye Drop Formulation B (Drug)
Carboxymethylcellulose Preservative-Free Lubricant Eye Drops
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
干预措施: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Drug)
Carboxymethylcellulose Based Lubricant Eye Drops
Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
干预措施: Carboxymethylcellulose Based Lubricant Eye Drops (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Disease Index© Questionnaire Score
时间窗: Baseline, Day 30
The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Tear Break-up Time(Baseline, Day 30)
- Change From Baseline in Corneal Staining(Baseline, Day 30)
- Change From Baseline in Conjunctival Staining(Baseline, Day 30)
- Change From Baseline in Schirmer Test Results(Baseline, Day 30)