Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Mean Bulbar Conjunctival Staining
研究概览
简要总结
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
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
- 否
入选标准
- •Non-contact lens wearer;
- •Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
- •Lipid deficiency;
- •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;
- •Other protocol-defined inclusion criteria may apply.
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 or recent ocular inflammation or 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;
- •Pregnant or lactating;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
SYSTANE BALANCE
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
干预措施: SYSTANE® BALANCE eyedrops (Other)
Minims Saline
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
干预措施: Minims® Saline 0.9% eyedrops (Other)
结局指标
主要结局
Mean Bulbar Conjunctival Staining
时间窗: Month 1
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
次要结局
- Non Invasive Tear Film Break-up-time (NIBUT)(Month 1)
- High Contrast logMAR Time Controlled Visual Acuity (TCVA)(Month 1)