Treatment of Ocular Demodex Infestation With Topical Ivermectin Cream 1%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparative density of sleeves
研究概览
简要总结
Patients with Demodex infestation of the eyelids will have the sleeves from both eyes cleaned off with microblepharoexfoliation. Afterwards, one eye will be randomly selected for treatment with topical ivermectin 1% cream. The treatment will be repeated on that eye 2 weeks later. Afterwards, participants will present monthly for photographs of the eyelashes. The photographs will be reviewed by an ophthalmologist outside of the study site who will be blind to which eye was treated and independently grade the amount of sleeves in each eye. The follow-up will be for 6 months after the second treatment for Group A eyes. At the 6 months point the second phase of the study will begin by treating the control eyes (now called Group B eyes) with a single application of ivermectin cream and no pre-treatment with microblepharoexfoliation.
详细描述
Informed Consent Form and Authorization to Use and Disclose Protected Health Information
Sponsor / Study Title:
Helm Vision Group / "Treatment of Ocular Demodex Infestation with Topical Ivermectin Cream"
Principal Investigator:
(Study Doctor) Craig Helm, MD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is blind to which eye was treated. Phase 1 is a single arm study in that only 1 treatment protocol is being tested in one eye and the contralateral eye is being used as the control. The initially treated eyes (Group A) will be followed for a total of 12 months. Phase 2 involves treating the initially untreated eyes after 6 months with a second protocol and following them for 6 months. Masking of the outcomes assessor is being done to eliminate bias from the treating physician.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent Moderate to dense sleeves No allergy to ivermectin Able to keep follow-up appointments
排除标准
- •Patients under 18 years old Allergy to ivermectin Inability to keep follow-up appointments
研究组 & 干预措施
Group A eyes
All participants will have one eye randomly selected for treatment after performing microblepharoexfoliation on both eye. After 2 weeks, a second application of ivermectin cream will be applied to the same previously treated eye.
干预措施: Ivermectin 1% cream (Drug)
Group B eyes
Group B eyes, which served as controls for the first 6 months of the study, will be treated with a single application of topical ivermectin cream without repeating the microblepharoexfoliation performed 6 months earlier.
干预措施: Ivermectin 1% cream (Drug)
结局指标
主要结局
Comparative density of sleeves
时间窗: Each patient will be followed for 6 months.
The density of sleeves will be clinically assessed and graded by the outcomes assessor
次要结局
- Modified SPEED Survey(From enrollment to the end of the follow-up 12 months after initiating treatment)
- Comparative assessment of tear osmolarity between treated and untreated eyes(Each patient will be followed for 6 months)
研究者
Craig J. Helm
Physician
Helm Vision Group