Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.
详细描述
This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-50 years old
- •Best corrected distance visual acuity ≥ 6/9
- •Mild to moderate OSDI score 13-32
- •Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)
排除标准
- •Any active ocular infections
- •Inflammations or anomalies in the eyelid
- •Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.
- •Pregnancy and breastfeeding
- •Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.
- •Subjects who are using artificial tears or other eyedrops will be excluded.
- •Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.
研究组 & 干预措施
Dry eye participants
Participants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT<10s; 3) osmolarity >=308, or difference >8
干预措施: Systane COMPLETE Lubricant Eye Drops (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: Change in OSDI score at 2-week visit
Change in OSDI score at 2-week visit
次要结局
- Non invasive tear break-up time (NITBUT)(NITBUT at 2-week and 3-month visits)
- Meibography(Meibography at 2-week and 3-month visits)
研究者
LAM Chuen Thomas, FAAO, PhD
Associate Professor
The Hong Kong Polytechnic University