NCT04780165已完成不适用
Prospective, Open Label, Multicenter Trial to Investigate the Efficacy and Tolerability of Blephademodex Wipes in Patients With Demodex Blepharitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Global Discomfort Score
研究概览
简要总结
Primary Objective
- To evaluate efficacy of Blephademodex eyelid hygiene wipe treatment with a subsequent maintenance period with Blephaclean lid cleansing wipes in Demodex blepharitis, as assessed by the change in ocular symptoms by a Global Discomfort Scale (GDS).
Secondary Objectives
- To evaluate the efficacy of Blephademodex eyelid hygiene wipe treatment in Demodex blepharitis as assessed by the change alone and in combination with a subsequent maintenance period of treatment with Blephaclean eyelid cleansing wipes ocular symptoms by: adapted TOSS; SANDE; specific blepharitis symptoms; Demodex count; ocular surface redness (Efron scale); lid margin redness/swelling (Efron / custom scale); Dandruff coverage at bases of eyelashes; ocular surface staining (Oxford scale; corneal only)
- To evaluate subject and physician satisfaction with Blephademodex eyelid hygiene wipes
- To evaluate ease of use for Blephademodex eyelid hygiene wipes
- Adverse events are documented and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years old, all genders
- •Able to read, to write and to fully understand German language
- •Good general health as determined by the investigator by medical history and physical appearance
- •Provision of written informed consent prior to inclusion
- •Moderate to Severe Blepharitis - grade ≥ 2 (Efron Scale)
- •Global discomfort score (GDS) ≥ 4
- •Proof of demodex infestation by at least ONE of the following:Demodex visible after lash manipulation;Cylindrical dandruff along the lash line; Lid margin itching; Madarosis
排除标准
- •History of ocular trauma, ocular infection or intra-ocular inflammation within the 3 months before screening visit
- •History of ocular refractive surgery and any other ocular surgeries within 3 months before screening visit
- •History of ocular allergy or ocular herpes within the 3 months before screening visit
- •History of inflammatory corneal ulcer within the 6 months before screening visit
- •Sjogren syndrome or any other rheumatologic disease related dry eye
- •Concurrent treatment with other eye drops (anti-infectives, steroids, prostaglandins (but artificial tears are ok).
- •Specific Exclusion Criteria for Women:Patient who verbally confirms pregnancy or lactation; Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch or condom) and is not surgically sterilised
结局指标
主要结局
Global Discomfort Score
时间窗: Day 56
Change from D28 at Day 56
次要结局
- Visual acuity(Day 56)
- Specific Blepharitis symptoms(Day 56)
- adapted Total Ocular Symptom Score (TOSS)(Day 56)
- Ocular surface redness(Day 56)
- Tolerability of the wipes(Day 56)
- Demodex count(Day 56)
- Lid margin redness/swelling(Day 56)
- Cylindrical dandruff(Day 56)
- Symptom Assessment in Dry Eye (SANDE)(Day 56)
- Ocular surface staining(Day 56)
- Physician's impression and patient impression(Day 56)
- Assessment of ease of use(Day 56)
研究者
研究点 (2)
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