NCT00705510已完成4 期
Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- NTBUT
研究概览
简要总结
To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time
详细描述
Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, of legal age of consent
- •Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
- •Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following
- •meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins
- •meibomian gland orifice inclusion (plugging) or abnormal of secretion
- •Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
- •Ability to follow study instruction and likely to complete all required visits
排除标准
- •Age < 18 years old
- •Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
- •Patients used cyclosporine within past 1 year
- •Patients used oral cyclosporine or anticholinergic drug within past 2 months
- •Patients with HIV or autoimmune disease
- •Patients with active ocular infections and patients with a history of herpes keratitis
- •Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
- •Female patients are pregnant or nursing
- •Patients who wear contact lenses
研究组 & 干预措施
A
Active Comparator
干预措施: 0.05% cyclosporin eye drop (Drug)
B
Placebo Comparator
干预措施: 0.05% cyclosporin eye drop (Drug)
结局指标
主要结局
NTBUT
时间窗: 0,1,2,3 month
次要结局
- OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining(0,1,2,3 month)
研究者
研究点 (1)
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