NCT04260893终止不适用
A Prospective Study Assessing The Impact Of Tixel Treatment On Dry Eye Symptoms And Signs In Asian Patients With Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Novoxel Ltd.
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- SAFETY, number of AEs
研究概览
简要总结
Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs in Asian Patients.
详细描述
Safety Assessment will be asses via AE/SAE reporting and Impact Assessment of the effect of the treatment on dry eye symptoms and signs through multiple
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
- 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
- •≥ 18 years.
- •OSDI score of at least
- •Noninvasive Tear film break up time (NIKBUT) ≤ 10 seconds.
- •No other eye or skin or immune problems.
- •Willing and able to provide written informed consent.
- •Willing to participate in all study activities and follow study instructions.
排除标准
- •Pregnancy and/or breastfeeding.
- •Lesions in the periorbital area.
- •Acute severe blepharitis.
- •Acute conjunctivitis.
- •Concomitant anterior eye disease.
- •Has undergone outdoor/sunbed tanning during the last 4 weeks.
- •Is unwilling to follow the Tixel aftercare instructions after each of the three Tixel treatments.
- •Active Herpes Simplex or tendency for Herpes Simplex in the periorbital area (meaning the subject has had the condition previously).
- •Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- •An impaired immune system condition or use of immunosuppressive medication.
- •Collagen disorders, keloid formation and/or abnormal wound healing.
- •Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course of the Tixel treatments, or before complete healing of the treatments has occurred.
- •Has taken any medications (including via topical application), herbal treatment (oral or topic), food supplements or vitamins, which may cause fragile skin or impaired skin healing during the last 3 months.
- •Has used oral Isotretinoin (Accutane® or Roaccutan®) within 3 months prior to treatment.
- •History of bleeding coagulopathies or use of anticoagulants.
- •Tattoos or permanent makeup in the areas to be treated.
- •Burned skin, blistered skin, irritated skin, or sensitive skin in any of the areas to be treated.
- •Thread lifting of the area to be treated in the last 3 months.
结局指标
主要结局
SAFETY, number of AEs
时间窗: 8 months
Any safety related event during the study will be recorded and analysed
NIBUT in Seconds
时间窗: 8 months
Non-Invasive Break Up Time
Ocular Surface Disease Index Questionnaire
时间窗: 8 months
OSDI Score; 12 Questions; answers between 0-4; Total calculated. Higher score means worst Dry Eye Symptomes
次要结局
- Tear Meniscus Height mm(8 months)
- Lid Wiper Epitheliopathy(8 months)
- Topography mm D(8 months)
- Staining; Total Ocular Staining Score(8 months)
- Osmolarity mOsml/L(8 months)
- Slit Lamp Exam; Normal, Abnormal(8 months)
- Meibography %(8 months)
研究者
研究点 (1)
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