A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ 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
- 460
- 主要终点
- Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
研究概览
简要总结
This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) 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
- 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
- 否
入选标准
- •Have used artificial tears for dry eye
排除标准
- •Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
- •History of eye surgery or trauma in the 6 months prior to study start
- •Current use or use within 2 weeks of study start, of topical eye medications.
研究组 & 干预措施
Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
干预措施: Carboxymethylcellulose Based Eye Drop Formulation A (Drug)
OPTIVE™
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
干预措施: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
时间窗: Baseline, Day 90
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.
次要结局
- Change From Baseline in Tear Break-up Time (TBUT)(Baseline, Day 90)
- Change From Baseline in Corneal Staining(Baseline, Day 90)
- Change From Baseline in Conjunctival Staining(Baseline, Day 90)
- Change From Baseline in the Schirmer Test(Baseline, Day 90)