NCT05011708已完成不适用
Examining Symptomatic Relief and Kinetic Stability of I-DROP MGD Eye Drops (LIME)
I-MED Pharma4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年8月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Non-Invasive Tear Break Up Time "NITBUT" duration
研究概览
简要总结
The objective of the study is to compare the difference in tear film stability and symptomatic relief between I-DROP MGD and another commercially available drop in the Canadian market.
详细描述
The purpose of this study is to:
- Compare tear film measurements for two hours after putting one drop of I-DROP MGD eye drops into one eye and one drop of Thealoz Duo eye drops in the other eye.
- Investigate the relief of dry eye symptoms with I-DROP MGD eye drops after 7 days of use.
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
- Double (Participant, Investigator)
盲法说明
Part 1 of the study will be double-masked (both investigator and participant are masked).
Part 2 will not involve masking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 18 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually uses ocular lubricants or artificial tears to relieve symptoms of dryness at least once per day for the past 30 days;
- •Has dry eye disease as per the TFOS DEWS II definition:
- •DEQ-5 ≥ 6 or OSDI ≥ 13
- •PLUS at least ONE of the following signs in at least one eye:
- •i. NITBUT < 10 seconds ii. >5 spots of corneal fluorescein staining OR > 9 conjunctival spots iii. Lid wiper fluorescein staining ≥ 2mm length ≥ 25% width.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has worn any contact lenses in the past 30 days;
- •Has previously, or currently uses I-DROP MGD eye drops;
- •Has any known allergy or intolerance to I-DROP MGD or Thealoz Duo eye drops;
- •Has any known active* ocular disease (allergies or inflammation) and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease);
- •Has a history of sensitivity to rapidly blinking lights or photosensitive epilepsy as one of the a key assessment device employs rapid blinking lights;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable (e.g. antihistamines);
- •Has known sensitivity to sodium fluorescein to be used in the study;
- •Self-reports that they are pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Has a undergone ocular surgery in the past 6 months;
- •Uses warm compress therapy, unless performed regularly, for a minimum of 30 days, and maintained at the same frequency throughout the duration of the study;
- •Unwilling to stop using their habitual ocular lubricants or artificial tears after Visit 2 (start of Part II);
- •Has been fitted with punctal plugs within 30 days prior to Screening;
- •Is a member of the Centre for Ocular Research & Education directly involved in the study;
- •Has taken part in another clinical research study within the last 30 days.
- •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 are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Non-Invasive Tear Break Up Time "NITBUT" duration
时间窗: Part I: 120 minutes after instillation
NITBUT is measured in seconds. A NITBUT less than 10 seconds indicates eye dryness
次要结局
- Ocular Surface Disease Index "OSDI" score((Part II: after 7 days of consecutive I-DROP MGD usage))
- Subjective measurement of "Change in comfort"((Part II: At baseline and after 7 days of consecutive I-DROP MGD usage))
- Subjective measurement of "Change in quality of vision"((Part II: At baseline and after 7 days of consecutive I-DROP MGD usage))
- Tear Meniscus Height (TMH) Assessment(Part I: 5-15-30-60-90-120 minutes after instillation)
- Lipid Layer Thickness (LLT) Assessment(Part I: 5-15-30-60-90-120 minutes after instillation)
- Subjective measurement of "Change in Dryness"((Part II: At baseline and after 7 days of consecutive I-DROP MGD usage))
- Subjective measurement of "Change in soothing"((Part II: At baseline and after 7 days of consecutive I-DROP MGD usage))
- Standard Patient Evaluation of Eye Dryness Score "SPEED questionnaire"((Part II: after 7 days of consecutive I-DROP MGD usage))
研究者
研究点 (4)
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