NCT00987727已完成4 期
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 82
- 主要终点
- Change From Baseline in Global Ocular Staining Score at Day 35
研究概览
简要总结
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
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
- Single (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 been using artificial tears for at least 3 months prior to study inclusion
- •Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
- •Having moderate to severe symptoms suggestive of dry eye
排除标准
- •Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
- •Moderate to severe blepharitis
- •History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
- •History or active signs of ocular allergic disease or ocular herpes within the last year
- •History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
研究组 & 干预措施
1
Experimental
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
干预措施: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) (Drug)
2
Active Comparator
sodium hyaluronate 0.18% (VISMED® Multi)
干预措施: sodium hyaluronate 0.18% (VISMED® Multi) (Drug)
结局指标
主要结局
Change From Baseline in Global Ocular Staining Score at Day 35
时间窗: Baseline, Day 35
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
次要结局
- Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35(Baseline, Day 35)
研究者
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