NCT02139033已完成4 期
A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With 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
- 入组人数
- 42
- 主要终点
- Tear Film Break-Up Time
研究概览
简要总结
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a reported history of dry eye;
- •Have a history of use or desire to use eye drops;
排除标准
- •Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used Restasis® within 30 days of Visit 1;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Be unwilling to submit a urine pregnancy test if of childbearing potential;
- •Have a known allergy and/or sensitivity to the test article or its components;
- •Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.
研究组 & 干预措施
Arm 1
Experimental
Retain 1-2 drops, bilaterally, BID
干预措施: Retaine™ (Drug)
结局指标
主要结局
Tear Film Break-Up Time
时间窗: Day 15
Ocular surface damage as measured by fluorescein staining
时间窗: Day 15
次要结局
未报告次要终点
研究者
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