NCT01386073Unknown4 期
Efficacy of FreshKote and Systane for the Treatment of Dry Eye and Improvement of Osmolarity
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- TBUT
研究概览
简要总结
The purpose of this study is to compare the efficacy of FreshKote and Systane for the reduction of dry eye signs and symptoms.
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
- 是
入选标准
- •Dry eye patients with Level 2 disease or greater as defined by the Delpi Panel
- •Tear osmolarity of at least 308 mosm
- •At least 18 years of age, Male or Female
- •Willing to provide written informed consent
- •Likely to complete all study visits
- •If currently using ocular lubricants, must complete a 10-14 day washout
排除标准
- •Presence of any active ocular disease other than dry eye
- •Use of topical ophthalmic medications
- •Use of contact lenses during the trial
- •Pregnant or nursing, or planning a pregnancy. Patients will be asked if they are pregnant or may be pregnant and excluded if they answer in the affirmative.
- •Any known sensitivity to any ingredients of either study drop
- •Oral anti-inflammatory medications, omega 3 supplements, or doxycycline
- •Punctal plugs inserted within the last 6 months or less
- •Uncontrolled systemic disease
- •Subjects with known sensitivity or inappropriate responsiveness to any of the medications used.
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- •Corneal abnormalities (e.g., ecstatic diseases, degenerations, or corneal dystrophies of the stroma or endothelium)
- •Concurrent participation or participation in the last 30 days in any other clinical trial
研究组 & 干预措施
FreshKote
Active Comparator
干预措施: FreshKote (Drug)
Systane
Placebo Comparator
干预措施: Systane (Drug)
结局指标
主要结局
TBUT
时间窗: Three months
Test that measures how long it takes for the tears to break up
Best Corrected Visual Acuity
时间窗: Three months
Vision obtained with the best possible lens correction (glasses or contact lenses)
次要结局
未报告次要终点
研究者
研究点 (2)
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