Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum

University of Waterloo1 个研究点分布在 1 个国家目标入组 17 人开始时间: 2019年5月29日最近更新: 2019年7月29日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Waterloo
入组人数: 17
试验地点: 1
主要终点: Participant's Subjective discomfort - 75 seconds after application

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum.

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: None

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

•Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
•Has read and signed an informed consent letter;
•Agrees to refrain from the use of ocular lubricants during the study period;
•Agrees to not to use eye-related cosmetics for upcoming study visits
•Is willing to use the study products
•Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule;
•Has corneal sensitivity within physiological limits.

排除标准

•Is participating in any concurrent clinical or research study;
•Is a contact lens wearer (due to reduced corneal sensitivity);
•Has any known active* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
•Has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable;
•Is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable;
•Has known sensitivity to the diagnostic pharmaceuticals to be used in the study (such as fluorescein dye to highlight structures of the eye and used regularly in optometric practice) and study products in this study;
•Is pregnant, lactating or planning a pregnancy at the time of enrolment; (due to the possibility of fluctuating vision as a consequence of variation in hormone levels);8
•Has undergone refractive error surgery (e.g. LASIK, PRK);
•Is a smoker (as smoking reduces tear film stability) * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye (Ocular Surface Disease Index, OSDI<23/100) are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

研究组 & 干预措施

Oust™ Demodex® Wipes™

Active Comparator

Participant cleans eyelids with Oust™ Demodex® Wipes™

干预措施: Oust™ Demodex® Wipes™ (Other)

I-LID N LASH PLUS® Eyelid Cleanser

Active Comparator

Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser

干预措施: I-LID N LASH PLUS® Eyelid Cleanser (Other)

Blephadex Lid Wipes

Active Comparator

Participant cleans eyelids with Blephadex Lid Wipes

干预措施: Blephadex Lid Wipes (Other)

Eye Cleanse Lid Wipes

Active Comparator

Participant cleans eyelids with Eye Cleanse Lid Wipes

干预措施: Eye Cleanse Lid Wipes (Other)

Blephademodex

Active Comparator

Participant cleans eyelids with Blephademodex

干预措施: Blephademodex (Other)

Sensitive Eyes® Plus Saline Solution

Placebo Comparator

Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution

干预措施: Sensitive Eyes® Plus Saline Solution (Drug)