Dry Eye Treatment With Artificial Tears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Symptoms
研究概览
简要总结
Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear quality and insufficient quantity. Treatments are traditionally in the form of artificial tears applied to the ocular surface. However, there is little evidence in the scientific literature that demonstrates their efficacy relative compared to each other, nor how to decide which one might be most effective for an individual patient. Therefore the investigators aim to examine the efficacy of different classes of artificial tears (those designed to increase viscosity, reduce evaporation or to mimic the component balance of the natural tears). In addition, the investigators also aim to determine how the treatment preferred by an individual could potentially have been predicted from their baseline condition.
详细描述
The efficacy of different classes of artificial tears (non-pharmaceutical) will be examined in patients that report dry eyes by prescribing each category of treatment [0.40% Sodium Hyaluronate (Clinitas Soothe), 0.15% Sodium Hyaluronate (Hyabak), 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears), and Phospholipid liposomal spray (Tears Again)] for a month in turn following a short wash-out period and to examine their tear film and ocular surface after each one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •subjective symptoms indicative of dry eye
排除标准
- •Sjögren's Syndrome
- •recent ocular infection
- •hay fever
- •used any eye drops or ocular medications,
- •were currently on medications known to affect the eyes
- •wore contact lenses
- •were pregnant.
研究组 & 干预措施
Tear Supplement Hypromellose 0.15%
Preservative free Hypromellose Eye Drops BP 0.15% applied as required for 1 month
干预措施: Hypromellose 0.15% (Other)
Tear Supplement Hypromellose 0.4%
Preservative free Hypromellose Eye Drops BP 0.4% applied as required for 1 month
干预措施: Hypromellose 0.4% (Other)
Tear Supplement Liposomal spray
Preservative free Phospholipid liposomal spray (Tears Again) applied as required for 1 month
干预措施: Liposomal Spray (Other)
Tear Supplement Carboxymethylcellulose
Tear Supplement 3: Preservative free 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears) applied as required for 1 month
干预措施: Carboxymethylcellulose (Other)
结局指标
主要结局
Symptoms
时间窗: 4 months
Short questionnaire (Ocular Surface Disease Index)
次要结局
- Ocular Surface Staining(4 months)
- Phenol Red Test(4 months)
- lid parallel conjunctival folds(4 months)
- Non-invasive break-up time(4 months)
- Tear meniscus height(4 months)