Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Meibomian Gland Secretion Quality
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of posterior blepharitis
- •A negative urine pregnancy test result for women of childbearing potential
- •Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
- •Normal lid position and closure
- •Ability to understand and provide informed consent to participate in this study
- •Willingness to follow study instructions and likely to complete all required visits.
排除标准
- •History of Stevens-Johnson syndrome or ocular pemphigoid
- •History of eyelid surgery
- •Intra-ocular surgery or ocular laser surgery within 3 months
- •History of microbial keratitis, including herpes
- •Active ocular allergies
- •Corneal epithelial defect > 1mm2
- •Use of topical steroids or Restasis within the past 2 weeks
- •Use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month
- •Use of isotretinoin (Accutane) within the past 6 months
- •Have had any previous treatment with Anakinra (Kineret®) or any therapeutic agent targeted at IL-1 blockade
- •Pregnant or lactating women
- •Signs of current infection, including fever and current treatment with antibiotics
- •Liver, renal, or hematologic disease
- •The use of any other investigational drug
研究组 & 干预措施
Treatment Arm 1
2.5% IL-1Ra
干预措施: 2.5% IL-1Ra (Drug)
Placebo
Artificial Tear
干预措施: Placebo (Drug)
Treatment Arm 2
5% IL-1Ra
干预措施: 5% IL-1Ra (Drug)
结局指标
主要结局
Meibomian Gland Secretion Quality
时间窗: 12 Week Time Point
Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Tear Breakup Time (TBUT)
时间窗: 12 Week Time Point
TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.
Corneal Fluorescein Staining Score
时间窗: 12 Week Time Point
Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Ocular Surface Disease Index (OSDI)
时间窗: Baseline and 12 Week Time Point data
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) x 100\]/\[(total number of questions answered) x 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning. OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12.
次要结局
未报告次要终点
研究者
Reza Dana, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary