Ocular Comfort and Markers of Inflammation in Subjects Undergoing Lid Hygiene Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Severity of Markers of Inflammation using tear osmolarity.
研究概览
简要总结
The primary study objectives are: to evaluate (1) the change in ocular discomfort at 30 days and (2) the change in signs and symptoms of ocular surface disease in demodex-positive subjects beginning the use of Avenova.
详细描述
This is a prospective study of subjects who have been diagnosed with bilateral demodex blepharitis. Qualified symptomatic eyes will be randomized and monitored for 30 days; one eye will undergo Avenova treatment twice daily and one eye will not undergo any study treatment.
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
- Single (Investigator)
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
- •Subject signed and dated a IRB-approved informed consent document
- •Mild or greater Demodex (minimum 15 observable mites in six lashes)
- •Score of 20 or more on the OSDI Questionnaire
- •Score of 20 or more on the Eyelid Inflammation Questionnaire
排除标准
- •Currently enrolled in another prospective research study
- •Unable to attend two follow-up visits over 30 days
- •Current allergic conjunctivitis of the cornea, conjunctiva, or eyelid in either eye
- •Prior ocular trauma where surgery was indicated
- •Prior corneal transplant in either eye
- •Any ocular surgery within the past six months
- •Abnormal corneal scarring, erosions, or Stevens-Johnson syndrome
- •Anticipation of ocular surgery within the next 30 days
- •Non-English speaking
- •Pregnant, nursing, or expect to become pregnant within the next 30 days
- •Known sensitivity to chlorine or Avenova
- •Moderate, or severe conjunctivochalasis
- •Contact lenses within the last 30 days and unwilling to discontinue for 30 days
- •Use of topical cyclosporine for less than 6 continuous months prior to baseline
- •Procedure such as pulsed light or commercial lid massage in last 30 days
- •Known history of autoimmune disease
- •Punctal plugs placed within the last 30 days
- •Use of Avenova or other lid cleansers within the last 30 days
- •Changes in systemic or ocular medications in the last 30 days
- •Unwilling to commit to the same ocular and systemic medications for 30 days
结局指标
主要结局
Change in Severity of Markers of Inflammation using tear osmolarity.
时间窗: 30 days
Clinical parameters include tear osmolarity.
Change in Severity of Markers of Inflammation
时间窗: 30 days
Clinical parameters include prevalence of demodex mites.
Change in Ocular Discomfort
时间窗: 30 days
Change in ocular discomfort based on scores from Eyelid Inflammation questionnaire.
次要结局
未报告次要终点