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N/A N=109 Randomized Single-blind Treatment

to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Meibomian Gland Dysfunction · Dry Eye Syndromes · Dry Eye

Enrolled (actual)
109
Serious AEs
4.7%
Results posted
Jan 2025
Primary outcome: Primary: Changes in Tear Break Up Times (TBUT) to the 4-weeks Follow-up Exam — 4.3; 4.6; 3.0; 2.7 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Tixel C (Device); LipiFlow (Device)
Age
Adult, Older Adult · 22+ yrs
Sex
All
Sponsor
Novoxel Ltd.
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Tear Break Up Times (TBUT) to the 4-weeks Follow-up Exam
4.3; 4.6; 3.0; 2.7
PRIMARY
Comparison of the Incidence of Device-related Ocular Adverse Events
0; 0
SECONDARY
Changes in Patient OSDI
50.2; 49.4; -26.4; -18.8; -28.6; -21.9
SECONDARY
Changes in Tear Break Up Times (TBUT) to the 12-weeks Follow-up Exam
4.3; 4.6; 3.1; 3.3
SECONDARY
Changes in MGS to 4-weeks and 12-weeks Follow-up Exam
7.2; 7.4; 9.0; 7.3; 11.3; 10.5
SECONDARY
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
2.8; 1.5; 2.6; 1.7; 2.7; 2.6
SECONDARY
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
3.1; 2.9; 2.1; 2.0; 1.4; 0.9
SECONDARY
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
13.3; 13.5; 0.4; 0.2; 0.1; 0.3
SECONDARY
Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline
2.4; 2.4; -0.9; -1.2; -1.3; -1.2

Summary

A Randomized, Masked (Evaluator), Controlled, Prospective Study Evaluating the Effectiveness and Safety of the Tixel® Medical Device, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Eligibility Criteria

Main Study (Stage1) Inclusion Criteria:

  • Age 22 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.
  • Reports dry eye symptoms for three months prior to the study.
  • Ocular Surface Disease Index (OSDI) score between 23-79.
  • Tear break-up time (TBUT) <10 seconds in both eyes.
  • 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.
  • Reports having to use artificial tears or lubricants regulatory over the past month to relieve dry eye symptoms.
  • Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
  • At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.

Main Study (Stage1) Exclusion Criteria:

  • History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 6 months.
  • Patient with giant papillary conjunctivitis.
  • Patient 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 any time.
  • Patient 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 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).
  • Use of any of the following medications:
  • Systemic medication(s) that is known to cause ocular dryness (e.g. antihistamine, diuretics, anti-hypertensives, anti-depressants, hormone therapy) whose dose of this medication(s) has not been stable within 30 days prior to enrolment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
  • Oral tetracyclines or azithromycin within 30 days prior to enrolment; or
  • Topical anti-glaucoma medications within 30 days prior to enrolment.
  • Any other systemic medication as per to the Investigator's discretion.
  • Women in childbearing age who are pregnant, nursing, or not utilizing adequate birth control measures.
  • Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution (Xiidra) within 45 days prior to study treatment (day 0), or any other dry eye or MGD medications (antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids) for at least 2 weeks 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 1 month prior study treatment (day 0), and at any point during the study.
  • Current skin canc
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05162261). 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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