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Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction | Clinical Trials | Clareo Health

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

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.

NCT04889950•Novoxel Ltd.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+22 more criteria

Locations (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Key Dates

Start Date

October 26, 2021

Primary Completion Date

January 4, 2023

Completion Date

February 8, 2023

Last Updated

November 15, 2024

Enrollment

ACTUAL participants

Conditions

Dry Eye SyndromesDry EyeMeibomian Gland Dysfunction

Interventions

Tixel C

DEVICE

LipiFlow

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

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