iLux Treatment for Meibomian Gland Dysfunction (MGD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
研究概览
简要总结
The purpose of this study is to assess changes in meibomian gland function and evaporative dry eye symptoms after treatment with the iLux medical device.
详细描述
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of written informed consent prior to study participation
- •Willingness and ability to return for all study visits
- •A positive history of self-reported dry eye symptoms for three months prior to the study using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and a score of >
- •Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes
- •Evidence of meibomian gland (MG) obstruction, based on a total meibomian gland secretion score of < 12 out of a maximum score of 45, for 15 glands (5 nasal, 5 medial, 5 temporal) of the lower eyelid of each eye. Glands expressed & graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
排除标准
- •History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
- •Ocular trauma or herpetic keratitis within the previous 3 months
- •Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- •Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
- •Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy
- •Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
- •Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
- •Ocular trauma, chemical burns, or limbal stem cell deficiency
- •Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)
- •Women who are pregnant, nursing, or not utilizing adequate birth control measures
- •Individuals who have either changed the dosing of systemic or ophthalmic medication within the past 30 days prior to screening or 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) within 2 months, or topical medications other than non-preserved artificial tears within 2 weeks.
- •Individuals using another investigational device or agent within 30 days of study participation
- •Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.
结局指标
主要结局
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
时间窗: Baseline (Day 0 pretreatment), Week 1, Month 1
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.
Change From Baseline in Tear Break-Up Time (TBUT)
时间窗: Baseline (Day 0 pretreatment), Week 1, Month 1
The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
次要结局
- Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score(Baseline (Day 0 pretreatment), Week 1, Month 1)
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score(Baseline (Day 0 pretreatment), Month 1)