Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change from Baseline of the SPEED questionnaire score at Day 90
研究概览
简要总结
This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.
详细描述
Enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. Patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). Patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (SPEED survey), Tear Breakup Time Measurement, Meibomian Gland Score, and a rapid in-office assessment of years (InflammaDry).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, 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
- •Age greater than18 at the time of informed consent
- •Clinical diagnosis of dry eye in both eyes
- •Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
- •The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
- •Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
- •Patient Evaluation of Eye Dryness (SPEED) questionnaire score >6 to <14
- •Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
排除标准
- •Any pre-existing ocular disease other than dry eye disease
- •Patients with inability to swallow soft gel capsules
- •Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
- •Drastic change of food and/or food supplements within the last month.
- •Other food supplement with fatty acids
- •Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.
- •Ocular surgery within the last 6 months.
- •Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.
- •Occlusion therapy with lacrimal or punctum plugs within the last 3 months.
- •Alterations of the lacrimal drainage system
- •Eyelid abnormalities
- •Patients on oral tetracycline or corticosteroids
- •Active allergy or infection at the ocular surface
研究组 & 干预措施
Sunflower Lecithin
Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules
干预措施: Sunflower lecithin (Dietary Supplement)
结局指标
主要结局
Change from Baseline of the SPEED questionnaire score at Day 90
时间窗: 90 days
To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic). Change = (Day 90 score - Baseline score)
次要结局
- Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90(90 days)
- Change in number of MMP-positive eyes at Day 90(90 days)
- Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90(90 days)