NCT00469573已完成4 期
Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes
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
- 36
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Men and women 18 and over
- •Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit.
- •Complaint of dry eyes
- •OSDI score > 23
排除标准
- •Use of RGP or PMMA contact lenses
- •Poorly fitting contact lenses
- •Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study
- •Concurrent use of topical medications other than study medications
- •Use of systemic medications with ocular drying sequelae:
- •Antihistamines
- •Decongestants
- •Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days
研究组 & 干预措施
1.
Other
干预措施: 1. Optive (Drug)
结局指标
主要结局
Safety
时间窗: 8 months
次要结局
- Efficacy(8 months)
研究者
研究点 (1)
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