Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 71
- 主要终点
- Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
研究概览
简要总结
To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of 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
- •Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
- •Be likely to complete the entire course of study and to comply with appropriate instructions
排除标准
- •Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
- •Have uncontrolled systemic disease
- •Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
- •Have anticipated contact lens wear during the study
- •Have an active ocular infection
研究组 & 干预措施
1
carboxymethylcellulose 0.5%, glycerin 0.9%
干预措施: carboxymethylcellulose 0.5% +glycerin 0.9% (Drug)
2
sodium hyaluronate 0.18%
干预措施: sodium hyaluronate 0.18% (Drug)
结局指标
主要结局
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
时间窗: Baseline, Week 2
Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.
次要结局
- Change From Baseline in Tear Breakup Time (TBUT) at Week 2(Baseline, Week 2)
- Change From Baseline in Corneal Staining at Week 2(Baseline, Week 2)
- Change From Baseline in Conjunctival Staining (Temporal) at Week 2(Baseline, Week 2)
- Change From Baseline in Conjunctival Staining (Nasal) at Week 2(Baseline, Week 2)