To Evaluate the Efficacy of 3% Diquafosol Sodium in the Treatment of Mild to Moderate MGD in Different Treatment Pattern
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The tear fluorescein break-up time changes at 12 weeks from baseline in both groups.
研究概览
简要总结
MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. It may result in alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. The meibomian glands, found in the upper and lower eyelids, excrete lipids onto the ocular surface that forms the outermost layer of the tear film, lubricating the ocular surface during blinking and protecting against tear evaporation.1 2 Through dysfunction of the meibomian glands, reduced lipid secretion may contribute to tear film instability and entry into the vicious circle of dry eye disease. The prevalence of MGD is higher in Asian populations, ranging from 46% to 70%.
The management and treatment subcommittee of the International Workshop on MGD proposed a treatment algorithm in which treatment is added depending on the severity of MGD. The sequence of treatment addition is eyelid hygiene, eyelid warming and massage, artificial lubricants, topical azithromycin, topical emollient lubricant, oral tetracycline derivatives, lubricant ointment, and anti-inflammatory therapy.
Topical diquafosol solution has been used to treat dry eye because it increases fluid secretion from conjunctival epithelial cells and mucin secretion from conjunctival goblet cells via the P2Y2 receptor. Because P2Y2 receptor expression is observed in sebaceous cells and ductal cells in the meibomian gland, diquafosol is expected to have some effects on meibomian glands. it has been reported that use 3% diquafosol ophthalmic solution in patients with obstructive MGD for more than 4 months. Ocular symptoms, lid margin abnormalities, the superficial punctate keratopathy score, and the meibum grade were decreased, while the tear breakup time, tear film meniscus area, and meibomian gland area were increased. These results suggest that topical diquafosol therapy is effective for patients with obstructive MGD. However, so far, no studies have reported the effect of DQS combined with eyelid hot compress and eyelid gland massage for MGD.
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
- 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
- •Patients with FBUT<10s；
- •Presence of ocular symptoms with OSDI score≥13；
- •0<The score of meibum quality or expressibility ≤2；
- •1/3≤The meibomian drop-out ≤2/3 (meiboscore ≤2)
排除标准
- •patients diagnosed of dry eye with Sjogren syndrome or diabetic mellitus.
- •Patients who wear contact lens during study or accepted refractive surgery within 6 months before screening.
- •Patients who have allergy history or adverse reactions to the experimental drugs or its components.
- •Patients with active ocular inflammation such as infectious keratitis or blepharitis.
- •Patients who had received ocular or system steroids or immunosuppressant 2 weeks before screening.
- •Patients who had received any other experimental drug 2 weeks before screening.
- •Patients with concomitant disease who were considered unable to evaluate efficacy or unlikely to complete the expected course of treatment and follow-up.
- •Pregnant and lactating women, or those planning a pregnancy over the course of the study.
- •Patients judged by the investigator to be unsuitable for the study.
研究组 & 干预措施
Group I:3% diquafosol
70 people, 70 eyes.
干预措施: 3% Diquafosol Sodium Eye Drops (Drug)
Group II:3% diquafosol and warm compresses and lid massage
70 people, 70 eyes.
干预措施: Warm compresses (Procedure)
Group II:3% diquafosol and warm compresses and lid massage
70 people, 70 eyes.
干预措施: 3% Diquafosol Sodium Eye Drops (Drug)
结局指标
主要结局
The tear fluorescein break-up time changes at 12 weeks from baseline in both groups.
时间窗: 12 weeks
The standard TBUT measurement was performed. After 1%fluorescein dye was instilled into the conjunctival sac, the interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated.
次要结局
- The tear fluorescein break-up time changes at 2 and 4 weeks from baseline in both groups.(2,4 weeks)
- The correlation between the change trend of meiboscore (meibomian gland drop our score)、meibomian glands opening score、meibum expressibility score、meibum quality score、LLT、corneal sensitivity and FBUT、CFS、OSDI.(12 weeks)
- The lid margin hyperaemia changes at 2 ，4 and 12 weeks from baseline in both groups(2,4 and 12 weeks)
- The TMH changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- meibum expressibility score changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The CFS changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The OSDI changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The LLT changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The changes of multi-measurement of Meibomian glands by meibography at 4 and 12 weeks from baseline in both groups(4 and 12 weeks)
- meibomian glands opening score changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The meiboscore (meibomian gland drop out score) changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- meibum quality score changes at 2 ，4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
- The changes of corneal sensitivity at 2, 4 and 12 weeks from baseline in both groups.(2,4 and 12 weeks)
研究者
Jin Yuan
Professor
Zhongshan Ophthalmic Center, Sun Yat-sen University