Randomized, Controlled Study With a Closed Sequential Design to Compare the Efficacy, Safety and Patient Satisfaction of Blephapad Combo vs. Standard Treatment for Eyelid Cleansing in Patients Affected by Bilateral Posterior Blepharitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NTC srl
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.
详细描述
Blepharitis is the most common condition in patients seeking an eye examination due to discomfort or eye irritation. Treatment of blepharitis is recommended even in mild cases as chronic inflammation may cause permanent damage to the Meibomian glands.
Each eye of each patient represents an experimental unit. Each patient will apply Blephapad Combo to one eye and standard treatment to the other eye in accordance with the randomization procedure.
The aim of this randomized, controlled study with a closed sequential design is to evaluate versus standard treatment the efficacy of, and patient satisfaction with Blephapad Combo in the treatment of posterior blepharitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years
- •Male or female
- •Diagnosis of bilateral posterior blepharitis
- •Written informed consent of patient
排除标准
- •Treatment with topical ophthalmic drugs (artificial tears allowed)
- •Ocular surgery in the previous 6 months
- •Pregnant or breastfeeding women
- •Alcohol abuse
- •Psychiatric disorders
- •Cognitive impairment that could affect evaluation of preferences
- •Participation in other clinical studies in the last month
- •Hypersensitivity to one or more components of the study products
结局指标
主要结局
Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)
时间窗: from baseline to week 4
The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome. The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features.
次要结局
- Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)(at Visit 3 (week 4))
- Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)(From Visit 2 (baseline) to Visit 3 (week 4))