NCT01010282已完成不适用
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 288
- 主要终点
- Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
研究概览
简要总结
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 at least twice daily, for at least three months prior to Day 1, on average
- •Ability/agreement to wear habitual correction (glasses) during study period
排除标准
- •Known allergy or sensitivity to the study product(s) or its components
- •Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
- •Chronic use of systemic medications which may affect a dry eye condition
- •Active ocular allergy or infection
- •Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
- •Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
研究组 & 干预措施
Glycerin and Polysorbate 80 based artificial tear
Active Comparator
Glycerin and Polysorbate 80 based artificial tear
干预措施: Glycerin and Polysorbate 80 based artificial tear (Drug)
结局指标
主要结局
Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
时间窗: Baseline (Day 1), Day 90
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
次要结局
- Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90(Baseline (Day 1), Day 90)
- Change From Baseline in Corneal Staining at Day 90(Baseline (Day 1), Day 90)
- Change From Baseline in Conjunctival Staining Severity Score at Day 90(Baseline (Day 1), Day 90)
- Change From Baseline in Tear Break-up Time (TBUT) at Day 90(Baseline (Day 1), Day 90)
研究者
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