NCT01051804已完成4 期
Evaluation of the Repeated Usage of Systane Ultra Eyedrop
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- Improvement in objective vision
研究概览
简要总结
Comparison of two contact lens solutions.
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 (Care Provider)
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
- •Age 18 years or more.
- •Non contact lens wearer.
- •Symptomatology as defined below for the Ocular Surface Disease Index (OSDI) questionnaire:
- •Score ≥13 for OSDI Questionnaire total score; AND
- •Scores of at least 2 for 2 out of the 6 vision related questions of the OSDI questionnaire
- •Best visual acuity of 6/9 or better in each eye.
- •Willingness to adhere to the instructions set in the clinical protocol.
- •Signature of the subject informed consent form.
排除标准
- •Use of systemic medication which might produce dry eye side effects.
- •Systemic disease which might produce dry eye side effects.
- •Active ocular infection.
- •Use of ocular medication.
- •Significant ocular anomaly.
- •Previous ocular surgery
- •Previous use of Restasis
- •Any medical condition that might be prejudicial to the study.
- •The subject, based on their knowledge, must NOT be pregnant or lactating at the time of enrolment.
- •The subject, based on his/her knowledge, must NOT have an infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. Human Immunodeficiency Virus).
- •The subject, based on their knowledge, must NOT have diabetes.
结局指标
主要结局
Improvement in objective vision
时间窗: 4 weeks
次要结局
- Measurement of tear film evaporation(4 weeks)
研究者
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