NCT06686368尚未招募4 期
Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial
I-MED Pharma0 个研究点目标入组 60 人开始时间: 2024年11月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Fluorescein Tear Break-Up Time (FTBUT) in seconds
研究概览
简要总结
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
详细描述
Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
All products will have their label removed and placed a white sticker showing the group (A or B or C). Products with be put in a white box with the letter indicated on it.
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
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and signed an information consent form.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
- •OSDI ≥ 13
- •And TBUT < 10 seconds
- •And >5 spots of corneal fluorescein staining OR > 9 conjunctival spots
- •Meibomian Gland score of 1 or higher using NEI grading criteria.
排除标准
- •Is participating in any concurrent clinical or research study.
- •Is wears contact lenses.
- •Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
- •Has undergone eye surgery involving the cornea or conjunctiva.
- •Aqueous deficient DED patients.
- •Is currently or has used any of the study drops in the last 3 months.
- •Has any known allergy or intolerance to any of the study drops.
- •Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
- •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 known sensitivity to sodium fluorescein.
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment?
- •Unwilling to stop using their habitual artificial tears for the study.
- •Has been fitted with punctal plugs within 30 days before the study screening visit.
- •Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.
结局指标
主要结局
Fluorescein Tear Break-Up Time (FTBUT) in seconds
时间窗: Day 1 - 30 minutes post installation
The primary outcome of the study is FBUT at 30 minutes post-installation
次要结局
- Fluorescein Tear Break-Up Time (FTBUT) in seconds(Day 7 - day 28)
- Tear Meniscus Height (TMH) in milimiters(Day 1 - Day 7 - day 28)
- Osmolarity in mOsm/L(Day 1 - Day 7 - day 28)
- Number of Corneal and Conjunctival spots(Day 7 - day 28)
- Ocular Surface and Disease Index (OSDI) score(Day 7 - day 28)
研究者
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