Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 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 purpose of this study is to investigate the efficacy of lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis compared to baby shampoo.
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 to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) 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
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)
Lid wipes containing terpinen-4-ol and sodium hyaluronate
The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
干预措施: Lid wipes containing terpinen-4-ol and sodium hyaluronate (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: 0-4-8-12 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 Demodex mite count by light microscopy(0-4-8-12 weeks)
- Efficacy of the treatment assessed by the change in the Schirmer test results(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 tear breakup time(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)
- Efficacy of the treatment assessed by the change in the meibomian gland loss(0-4-8-12 weeks)
研究者
Ceyhun Arici, MD
Associate Professor
Istanbul University - Cerrahpasa (IUC)