NCT01684852已完成不适用
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution (BAT04) Compared to HA Eye Drops in the Treatment of Dry Eye Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Tear Break Up Time
研究概览
简要总结
This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Male or female person aged 18 years
- •Demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye")
- •Acute symptoms of dry eye: DEWS 1-3
- •tear break-up time TBUT <10s
- •agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist)
排除标准
- •inflammation of the anterior segment or trauma
- •Contact lens wearers
- •Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
- •Patients with known intolerance to one of the substances used
- •Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial
- •patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent
结局指标
主要结局
Tear Break Up Time
时间窗: V1 and V2
次要结局
未报告次要终点
研究者
研究点 (5)
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