NCT02461719已完成3 期
Multicenter, Randomized, Double-blind phⅢ Study of TJCS Eye Drops Group and Restasis Eye Drops Group for 12 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Corneal staining test
研究概览
简要总结
The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 20 or over
- •Patients with moderate to severe dry eye
- •Screening both eyes, the corrected visual acuity is 0.2 or more
排除标准
- •Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
- •Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- •Intraocular pressure(IOP)> 25 mmHg
- •Patient using or to use punctual plug within 1 months.
- •Patients with contact lens.
研究组 & 干预措施
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Experimental
CYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
干预措施: CYPORIN N EYE DROPS 0.05%(TJCS eye drop) (Drug)
Restasis eye drop
Active Comparator
Restasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
干预措施: Restasis (Drug)
结局指标
主要结局
Corneal staining test
时间窗: 12 weeks
次要结局
- Tear break up time (TBUT)(4, 8, 12 weeks)
- Non-anesthetic Schirmer test(4, 8, 12 weeks)
- Corneal staining test(4, 8 weeks)
- Conjunctival staining(4, 8, 12 weeks)
- Corneal and Conjunctival staining sum Score(4, 8, 12 weeks)
- Ocular surface disease index (OSDI)(4, 8, 12 weeks)
- Frequency of concurrent drug use(4, 8, 12 weeks)
研究者
研究点 (1)
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