Tear Osmolarity Clinical Utility in Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Osmolarity change
研究概览
简要总结
Millions of people suffer from dry eye disease, causing symptoms such as redness, burning, feeling of sand or grit in the eye and light sensitivity. Dry eye disease occurs when your eyes do not produce enough tears or produce poor quality tears. This can happen for a number of reasons, including aging, hormonal changes in women and side effects of diseases or medications.
It is now possible to objectively measure the degree of dry eye disease by collecting a tiny sample of tears from the corner of the eye and then measuring the amount of salt in the tears (termed osmolarity). We aim to establish the overall levels of raised and normal tear osmolarity in people presenting to the eye clinic with complaints of dry eye, and relate this to other factors such as symptoms, topical and nutritional medication and dry eye treatment.
详细描述
This study will investigate the efficacy of two treatment non-pharmaceutical therapies (tear drop alone, tear drop combined with omega 3 nutritional supplement and warm compresses) for dry eye reporting patients against a control (saline) over a 3 month period. A relatively new clinical measure (osmolarity) will be performed alongside traditional tear film volume, tear film stability, gland integrity and ocular surface damage measures to determine how this influences symptomatic complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Dry Eye Symptoms SPEED >8
排除标准
- •Unable to participate in 90 days therapy
- •Allergic to therapy
- •On medication known to affect ocular surface / tear film
- •Had ocular trauma, infection or surgery
- •Diagnosed with a medical condition known to affect ocular surface / tear film
研究组 & 干预措施
Control
Minims Saline (Preservative Free) lubricant eye drops - daily for 90 days
干预措施: Saline (Other)
Hypromellose - standard treatment
Tear Supplement: Hypromellose 0.3% eye drops - daily for 90 days
干预措施: Tear supplement (Other)
Combination treatment
Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;
干预措施: Tear supplement 2 (Other)
Combination treatment
Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;
干预措施: Omega 3 nutrition supplement (Dietary Supplement)
Combination treatment
Tear Supplement 2: Hylo-Forte 0.2% Sodium Hyaluronate eye drops, Omega 3 nutrition supplement: Omega-3 tablets, Eye bag: TranquilEyes Moist Heat Lid Compresses - Daily for 90 days;
干预措施: Eye bag (Device)
结局指标
主要结局
Osmolarity change
时间窗: 3 months
Salt balance in tears measured with the Tearlab
次要结局
- Tear break-up time change(3 months)
- Corneal staining change(3 months)
- Tear Meniscus Height(3 months)
- SPEED Questionnaire change(3 months)
- Meibomian gland change(3 months)