Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
研究概览
简要总结
The aim of the study was to compare the efficacy of lid swabs containing tea tree oil (TTO) and chamomile oil and baby shampoo (BS) in the treatment of seborrheic blepharitis.
详细描述
After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio using block randomization to lid wipes containing tea tree oil (TTO) and chamomile oil or baby shampoo (twice daily).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of seborrheic blepharitis
排除标准
- •Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
- •Patients younger than 18-year-old
- •Patients who used any treatment for blepharitis within the 6 months prior to the examination
研究组 & 干预措施
Swabs containing tea tree oil and chamomile oil
The swabs will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
干预措施: Swabs containing tea tree oil and chamomile oil (Drug)
Baby shampoo
Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks
干预措施: Baby shampoo (Drug)
结局指标
主要结局
Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
时间窗: Change from Baseline at 12 weeks
BLISS score is calculated according to the answers given to the questionnaire. Higher BLISS scores is related to a worse outcome. (Range is between 0 and 39)
次要结局
- Efficacy of the treatment assessed by the change in the Schirmer's test results(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in the tear breakup time(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in the ocular surface disease index score(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in the meibomian gland loss(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in the non-invasive tear breakup time(0-4-8-12 weeks)
研究者
Ceyhun Arici, MD
Associate Professor
Istanbul University - Cerrahpasa (IUC)