Pilot Project: Comparing the Short-term Effects on the Tear Film and Lid Margin Between Diluted Baby Shampoo and Blephaclean
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- NIKBUT
研究概览
简要总结
Lid cleansing is the standard regime that is recommended for the management of blepharitis in the UK and beyond. Whilst many successful commercial preparations exist, and some with clinical evidence, professional guidelines (UK Royal College of Ophthalmologists, UK College of Optometrists, AAO, etc.) continue to advocate the use of a diluted solution of baby shampoo, despite no clinical evidence of its safety, tolerance or long term effectiveness, and despite a statement form the manufacturers that it should not be used for this purpose. Where licensed, registered products exist it seems bizarre that we have this situation, but a Cochrane review from 2012 indicated that only a longitudinal, randomized controlled trial against baby shampoo would alter their conclusions. Whilst that sort of clinical study is possible, it is proposed here to start with a short-term study to look at the immediate changes induced in the tear film and ocular surface when comparing baby shampoo with Blephasol solution, in a blind, randomized controlled trial.
详细描述
Aims/Key Questions: The hypothesis is: Diluted baby shampoo is more disruptive and deleterious to the human tear film and ocular surface than Blephaclean solution. It is expected that there will be a clinically meaningful difference (approximately 30%) in the non-invasive tear-break up time after the application of baby shampoo compared to Blephaclean.
Potential outcomes: To raise awareness that the safety profile of baby shampoo is insufficient to make it a professional and ethical recommendation for daily lid hygiene.
Recruitment: All subjects will be recruited from the staff and student population of the Faculty of Health and Human Sciences, Plymouth University as well as patients of The Centre for Eyecare Excellence (CEE) and Well-being centre (WBC) at Plymouth University. The recruitment will be carried out via email, flyers and direct invitation. After the first contact, the information sheet, as well as the informed contents, will be sent, or a printed version will be given to all potential subjects.
Design: This prospective study is a two-visit, prospective, cross-sectional, double-blinded and randomized controlled trial. The basic population is described as a healthy UK population with diverse ethnic backgrounds and physiological variation. The principal investigator will carry out the data collection at the Peninsula Allied Health Centre, CEE or WBC (Plymouth University). Ethical approval was grantet. This study conforms to the ethical principles of the Declaration of Helsinki, ICH guidelines for Good Clinical Practice (GCP) and Plymouth University's Principles for Research Involving Human Participants.
Sample size calculations were performed for detecting differences between two dependent not-normally distributed means. A maximum effect size (NIK-BUT difference after the application of baby shampoo compared to Blephaclean) of 0.4 is expected with alpha=0.05 and beta=0.20 (80% power). A sample size of 52 will be required. If considering potential dropouts, the study will aim to recruit 60 subjects. The effect size was calculated based on the distribution of the NIK-BUT in healthy eyes (Abdelfattah et al. 2015).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be over 18 and under 60 years of age
- •Completed a comprehensive eye exam in the last two years
- •Contact lens wearers must have stopped wearing for a minimum of two days if wearing soft contact lenses and one week if wearing RGP lenses.
- •The subject must have an adequate understanding of the English language to be able to comprehend the oral and written instructions.
排除标准
- •Determination during enrolment:
- •Pregnancy or breast-feeding whilst the examination
- •Application of any eye drops within the last 48 hours before the examination
- •Application of medication within the last 30 days which influences the body water regulation system (e.g. antidepressants, diuretics, corticosteroids, histamine-receptor antagonist, immune-modulators)
- •Change of ocular therapy within the last 30 days before the examination
- •Permanent application of eye drops or ocular medication
- •On-going ocular treatment
- •Any kind of ocular pathology or history of refractive surgery
- •Any kind of systemic disease which affect collagen and the body water regulation system (Marfan syndrome, osteogenesis imperfect, pseudoxanthoma elasticum, Ehlers-Danlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)
- •Early termination of the study:
- •Drop-out: active termination (decision made by the test person)
- •Decision made by the examiner (inadequate compliance, change in the medical condition, as a result, the exclusion criterion is fulfilled)
- •Decision made by the lead investigator/ sponsors
- •It is possible to withdraw the participation in the study at any time. The participant is not liable to give any reasons for withdrawing. If the study is withdrawn because of the decision of the investigator, the reasons must be given in the screening form.
结局指标
主要结局
NIKBUT
时间窗: 1 day
Non-invasive break up time
次要结局
未报告次要终点
研究者
Dr Daniela Oehring
Dr
University of Plymouth