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N/A N=21 Randomized Single-blind Treatment

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

Dry Eye Syndromes · Dry Eye · Meibomian Gland Dysfunction

Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater — 4.0; 1.9; 3.4; 4.7 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tixel C (Device); LipiFlow (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Novoxel Ltd.
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
4.0; 1.9; 3.4; 4.7; 7.4; 6.6
PRIMARY
Comparison of the Incidence of Device-related Adverse Events for the Two-treatment Arms.
0; 0
SECONDARY
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
42.7; 47.6; 22.0; 38.2; 27.0; 32.4
SECONDARY
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
2.5; 4.5; 13.7; 5.6; 9.8; 13.9
SECONDARY
Overall Changes From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater.
4.2; 1.6
SECONDARY
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
3.9; 0.5; 3.6; 2.8; 3.7; 0.9
SECONDARY
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
6.6; 3.6; 6.6; 3.6; 2.0; 1.2
SECONDARY
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
-0.3; -3.3; -1.5; -1.5; 0.2; -0.1
SECONDARY
Lissamine Green Staining Scores and the Changes From Baseline
6.1; 4.7; 5.4; 3.1; 1.5; 1.0

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04889950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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