Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 7
- 主要终点
- Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
研究概览
简要总结
The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.
详细描述
At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.
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
- Single (Outcomes Assessor)
盲法说明
Meibomian gland score will be assessed by a masked rater
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
- •Age 18 years and older of any gender or race
- •Written informed consent to participate in the study
- •Willingness and ability to return for all study visits
- •Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit
- •Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
- •Tear break-up time <10 seconds
- •Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)
排除标准
- •History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
- •Subjects with giant papillary conjunctivitis
- •Subject with punctal plugs or who have had punctal cautery
- •Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination
- •Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months
- •Subjects who are aphakic
- •Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- •Active ocular infection
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- •Ocular surface abnormality that may compromise corneal integrity
- •Lid surface abnormalities that affect lid function in either eye
- •Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
- •Systemic disease conditions that cause dry eye
- •Unwillingness to abstain from systemic medications known to cause dryness for the study duration
- •Women who are pregnant, nursing, or not utilizing adequate birth control measures
- •Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening
- •Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study
- •Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)
- •Individuals wearing contact lenses at any time during the prior three months or during the study period
- •Eyelid tattoos, including permanent eyeliner makeup
- •Individuals that were treated with LipiFlow in either eye in the last 24 months
- •Individuals using another ophthalmic investigational device or agent within 30 days of study participation
- •Individuals who are unable to complete the required patient questionnaires in English
研究组 & 干预措施
iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
干预措施: iLux 2020 System (Device)
LipiFlow Thermal Pulsation System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
干预措施: LipiFlow Pulsation System (Device)
结局指标
主要结局
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
时间窗: Baseline, Week 4
Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Incidence (Number) of Device- or Procedure-related Adverse Events
时间窗: Week 4
The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
时间窗: Baseline, Week 4
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.
次要结局
- Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)(Baseline, Week 4)
- Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)(Baseline (Day 0), Immediately Post-Treatment (Day 0))
- Change From Baseline to Post-Treatment in Ocular Surface Staining(Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment)
- Mean Pain Score During Treatment(Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment)
- Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)(Baseline (Day 0), Immediately Post-Treatment (Day 0))
- Mean Discomfort Score During Treatment(Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment)