Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Serum cytokine level
研究概览
简要总结
Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no randomized controlled study has been done. So the investigators evaluate the effectiveness and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N = 30).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is diagnosed with primary Sjögren syndrome according to American/European consensus group (AECG) criteria
- •Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial
排除标准
- •Previous treated by Hydroxychloroquine but enough washout time after discontinuance of treatment, patient can be enrolled. (2 wks)
- •Known cardiac disease, Respiratory disease, Renal disease, Gastrointestinal disease (except GERD)
- •Diabetes mellitus
- •Psoriasis
- •Known drug allergy or hypersensitivity
- •Previous or ongoing treatment by any drugs (include topical drug) which have effect on lacrimal system. But enough washout time after discontinuance of treatment, patient can be enrolled. (cf. SSRI, Anti-histamine, Pilocarpine, etc.)
- •Angle closer glaucoma
- •Patient who underwent previous intraocular surgery
- •Macular disease
- •Previous or ongoing treatment by drug which could have effect on macula
- •Pregnancy
- •Planning to get pregnant
研究组 & 干预措施
Hydroxychloroquine
Hydroxychloroquine 300 mg once daily p.o.
干预措施: Hydroxychloroquine (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Serum cytokine level
时间窗: 16 weeks
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
次要结局
- Tear cytokine level(16 weeks)
- Retinal exam(16 weeks)
- Indicator of inflammation(16 weeks)
- Tear production(16 weeks)
- Subjective clinical eye complaints(16 weeks)
- Visual acuity(16 weeks)
- Tear breakup time(16 weeks)
- Corneal punctate fluorescein staining score(16 weeks)
- Changes in serum T-cell property(16 weeks)
- Color test(16 weeks)