NCT02229955已完成3 期
A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment 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
- 86
- 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 Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) 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.
- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[Patients with moderate-to-severe ocular dry eye]
- •The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
- •Non-anesthetic Schirmer test value ≤ 10mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value ≥ 3mm/5min)
- •Tear break-up time is 10 seconds or less
- •Screening both eyes, the corrected visual acuity is 0.2 or more
- •Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
排除标准
- •Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
- •The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- •Abnormal eyelid function : Disoders of the eyelids or eyelashes
- •Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
- •Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation
- •current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- •The use in clinical trials of drug hypersensitivity reactions in patients
研究组 & 干预措施
T-sporin eye drop
Experimental
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
干预措施: Cyclosporine ophthalmic solution (Drug)
Restasis eye drop
Active Comparator
Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
干预措施: Cyclosporine ophthalmic solution (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)
- Ocular surface disease index (OSDI)(4, 8, 12 weeks)
- Non-anesthetic Schirmer test(4, 8, 12 weeks)
- Corneal staining test(4, 8 weeks)
- Conjunctival staining(4, 8, 12 weeks)
研究者
研究点 (1)
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