A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study of the Effectiveness and Safety of the Tixel Versus Lipiflow in the Treatment of Meibomian Gland Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novoxel Ltd.
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
研究概览
简要总结
A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study of the Effectiveness and Safety of the Tixel®, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction. Up to 30 patients (60 eyes) to be randomized in up to 2 clinical sites in Israel and/or Europe. study subject will receive three (3) treatments with Tixel in a monthly interval, and a single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment.
详细描述
Up to 30 patients (60 eyes), 15 Per Device at up to 2 study sites in Israel and/or Europe will be recruited to evaluate the safety and effectiveness of the Tixel device in adults with Meibomian Gland Dysfunction (MGD). study subject will receive three (3) treatments with Tixel in a monthly interval, and single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment.
Tixel group study visits will be as follow:
Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatments - three treatments will be conducted to the study device group. Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last treatment.
Control group visit will be as follow:
Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatment- single Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last 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
Blinded Evaluator
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 Ocular Surface Disease Index (OSDI) questionnaire, and a score of ≥ 23 at the baseline visit.
- •Evidence of meibomian gland (MG) obstruction, based on a total Meibomian Gland Score (MGS) of ≤12 in the lower eyelids for each eye. The rater of MGS must not be involved in the study procedure.
- •Tear break-up time (TBUT) <10 seconds. The rater of TBUT must not be involved in the study procedure.
- •Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
- •Fitzpatrick skin type I-VI
排除标准
- •History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year.
- •Patients with giant papillary conjunctivitis.
- •Patients 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.
- •Patients who are aphakic.
- •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 may affect lid function in either eye.
- •Anterior blepharitis (staphylococcal, demodex, or seborrheic grade 3 or 4).
- •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).
- •Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
- •Women in child bearing age who are pregnant, nursing, or not utilizing adequate birth control measures.
- •Individuals who have changed the dosing of either systemic or non-dry eye/MGD ophthalmic medication 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 (Xiidra) within 3 months, or any other dry eye or MGD medications (antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids) for at least 2weeks; and to maintain abstinence throughout the duration of the study (ocular lubricants are allowed if no changes are made during the study).
- •Individuals wearing contact lenses at any time during the prior three months and at any point during the study.
- •Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
- •An impaired immune system condition or use of immunosuppressive medication.
- •Collagen disorders, keloid formation and/or abnormal wound healing.
- •Previous invasive/ablative procedures in the areas to be treated within 3 months prior to initial treatment or plans for such treatment during the course treatment, or before complete healing of such treatments has occurred.
- •Any patient who takes or has taken any oral or topical medications, herbal treatment, food supplements, or vitamins which may cause fragile skin or impaired skin healing during the last 3 months.
- •Any patient who has a history of bleeding coagulopathies.
- •Any patient who has tattoos or permanent makeup in the treated area.
- •Any patient who has burned, blistered, irritated or sensitive skin in any of the areas to be treated.
- •Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
- •Individuals that were treated in either eye with LipiFlow in the last 24 months, or Tixel at any point in the past.
- •Treatment in either eye with IPL in the last year.
- •Expression of the meibomian glands within 6 months prior to screening.
- •Use of at home warm compresses or lid hygiene products while participating in study.
结局指标
主要结局
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
时间窗: Tixel arm: Baseline and 4 weeks after last treatment (8 weeks post baseline). LipiFlow arm: Baseline and 4 weeks after treatment (4 weeks post baseline).
Change from baseline to the 4-weeks follow-up exam in Tear Break Up Times (TBUT), as assessed by a masked rater. TBUT - Tear Break-Up Time, is a clinical test used to evaluate the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to appear on the cornea after a blink. A shorter TBUT indicates a more unstable tear film, which can be a sign of dry eye disease or other ocular surface disorders. Tear Break-Up Time (TBUT) is typically scored by the time (in seconds). The general interpretation of TBUT scores is as follows: Normal TBUT: More than 10 seconds Borderline TBUT: 5 to 10 seconds Abnormal/Low TBUT: Less than 5 seconds
Comparison of the Incidence of Device-related Adverse Events for the Two-treatment Arms.
时间窗: Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).
Comparison of the incidence of device-related adverse events (e.g., increase in the lid margin such as development of floppy eyelids, entropion or ectropion; and lash integrity) for the two-treatment arms.
次要结局
- Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).(Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).)
- Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.(Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).)
- Overall Changes From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater.(Tixel arm: Baseline and 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline and 12 weeks after treatment (12 weeks post baseline).)
- Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)(Tixel arm: 4 weeks (treatment 1- day 0, treatment 2- 2 weeks, treatment 3- 4 weeks). LipiFlow arm: On treatment day - day 0 (only one treatment for this arm))
- Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline(Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).)
- The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms(Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).)
- Lissamine Green Staining Scores and the Changes From Baseline(Tixel arm: Baseline to 12 weeks after last treatment (16 weeks post baseline). LipiFlow arm: Baseline to 12 weeks after treatment (12 weeks post baseline).)