EUCTR2015-000937-54-NO进行中（未招募）1 期
A phase II, multicenter, randomized, double-masked, 4 parallel arms, controlled 6-month trial designed to evaluate the safety and efficacy of PAD ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy and a 3-month post-treatment safety follow-up in moderate to severe dry eye patients
DRUG DELIVERY SOLUTIONS ApS (PART OF MC2 BIOTEK GROUP)0 个研究点目标入组 263 人开始时间: 2015年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 263
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients are at least 18 years of age
- •2.Patients with at least a 3 month documented history of moderate to severe DED persisting despite conventional management (which may include artificial tear drops, gels, ointments and/or punctual occlusion), and defined as the following:
- •a.Corneal fluorescein staining (CFS) = 3 or 4 (modified Oxford scale, scale 0 – 5)
- •b.Global ocular discomfort score of = 30mm using a 100 mm VAS. Patients will assess burning/stinging, foreign body sensation, eye dryness and pain and the mean score will be calculated: (where 0 means no symptom and 100 means the worst that have ever experienced).
- •3.Patients must provide written informed consent
- •4.Patients must be willing and able to undergo and return for scheduled study-related examinations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 77
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 143
排除标准
- •Patients presenting with any of the following will not be included in the study:
- •1.History of the disease for less than 3 months (symptoms stabilized)
- •2.Best corrected distance visual acuity (BCDVA) score = +1.0 LogMAR (= 35 ETDRS letters, = 20/200 Snellen or = 0.1) in each eye
- •3.Within the 3 months before the screening visit, history of ocular trauma, infection (viral, bacterial, fungal), inflammation not associated with dry eye
- •Other exclusion criteria are defined in the protocol (they are referring to the ocular history, the medical history and the contraindications to treatment).
研究者
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