Clinical Study to Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Dry Eye, Dry Eye Syndromes, Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: Tixel C
* Device: LipiFlow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized, Masked (Evaluator), Controlled, Prospective Pilot Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tixel Group<br>Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. | Device: Tixel C<br>* Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.<br>|
| Active Comparator: LipiFlow<br>LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. | Device: LipiFlow<br>* LipiFlow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tear Break Up Times (TBUT), as assessed by a masked rater | Change from baseline to the 4-weeks follow-up exam in Tear Break Up Times (TBUT), as assessed by a masked rater | 18 months | 
| Comparison of the incidence of device-related adverse events for the two-treatment arms. | 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI). | Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam. | 18 months | 
| Changes from baseline exam in Meibomian Gland Score (MGS), as assessed by a masked rater. | Changes from baseline to 4-weeks and 12-weeks follow-up exam in Meibomian Gland Score (MGS), as assessed by a masked rater. | 18 months | 
| Changes from baseline in Tear Break Up Times (TBUT), as assessed by a masked rater. | Changes from baseline to the 12-weeks follow-up exam in Tear Break Up Times (TBUT), as assessed by a masked rater. | 18 months | 
| During treatment Discomfort and pain questionnaires (each self-assessed by VAS) | Discomfort and Pain from the treatment (Tixel or LipiFlow) using the questionnaires assessed by the subject. These are visual analogue scale (VAS) questionnaires using a scale from 0-10 to assess eye discomfort and pain. Both questionnaires are to be self-assessed by the patient immediately following treatment. | 18 months | 
| Changes from baseline in: Ocular Surface Staining. Intraocular Pressure. Cornea OCT evaluation to detect changes (cornea thickness, cornea delamination) | Changes from baseline following treatment for the test and control devices for the following assessments: Ocular Surface Staining. Intraocular Pressure. Cornea OCT evaluation to detect changes (cornea thickness, cornea delamination) following treatment- will be performed on a subset of 10 patients, who first enrolled, only in the Tixel arm. | 18 months |