NCT04649606已完成不适用
Dynamic Characterisation of Meibomian Gland Structure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Meibomian Gland Appearance - Mean Reflectivity
研究概览
简要总结
This will be a single center pilot study to evaluate appearance of the Meibomian glands.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Healthy adult males and females, 18-40 years of age (inclusive)
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
- •The subject must agree not to participate in other clinical research for the duration of this study
- •The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
- •The subject's refractive cylinder must be ≤-1.00 DC in each eye
- •The subject must score less than 4 points (inclusive) in SPEED questionnaire
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating
- •Any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g. HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
- •Have had cataract surgery
- •Use of systemic medications (e.g. chronic steroid use) and any current use of ocular medications (e.g. lubricants, artificial tears) that would interfere with participation in the trial, at the Investigator's discretion
- •They have history (more than one week in total) of contact lens wear.
- •Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, corneal distortion or keratoconus
- •History of allergy to sodium fluorescein or lissamine green
- •Any Grade 1.5 or greater slit lamp findings (e.g. oedema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron Grading Scales or other ocular abnormality including Meibomian gland dysfunction (MGD) or blepharitis (Grade 1.0 or greater)
- •Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid
- •The central glands atrophy exceeds 25% (inclusive)
- •The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only)
- •Use of eye makeup on the days of the study visits
- •Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment
- •Employee or immediate family member of an employee of clinical site (e.g. Investigator, Coordinator, Technician)
结局指标
主要结局
Meibomian Gland Appearance - Mean Reflectivity
时间窗: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the mean reflectivity of individual and aggregated Meibomian glands
Meibomian Gland Appearance - Area
时间窗: up to 4-week follow-up
Meibomian gland appearance will be evaluated on both eyes using a custom image analysis algorithm, which calculates the area corresponding to individual and aggregated Meibomian glands.
次要结局
- Tear Film Evaporation Rate(up to 4-week follow-up)
- Non-Invasive Tear Break-Up Time (NIBUT)(up to 4-week follow-up)
- Lipid Layer Thickness (LLT)(up to 4-week follow-up)
研究者
研究点 (1)
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