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

NCT05162261 | Completed Results FDA Device

• 1 other identifier: CLN 0858
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes; Dry Eye

Outcome Measures

Primary Outcomes (2)

• Changes in Tear Break Up Times (TBUT) to the 4-weeks Follow-up Exam

  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

  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).

• Comparison of the Incidence of Device-related Ocular Adverse Events

  Comparison of the incidence of device-related Ocular adverse events for the two treatment 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).

Secondary Outcomes (7)

• Changes in Patient 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).

• Changes in Tear Break Up Times (TBUT) to the 12-weeks Follow-up Exam

  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).

• Changes in MGS to 4-weeks and 12-weeks Follow-up Exam

  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 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).

Other Outcomes (3)

• Extension Study Endpoint 1

  Baseline and 6 months post-last treatment (7 months post-baseline)

• Extension Study Endpoint 2

  Baseline and 6 months post-last treatment (7 months post-baseline)

• Extension Study Endpoint 3

  Baseline and 6 months post-last treatment (7 months post-baseline)

Study Arms (2)

Tixel Group

EXPERIMENTAL

Screening and baseline visits, Treatment- 3 treatment sessions, 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: Tixel C

LipiFlow

ACTIVE COMPARATOR

LipiFlow: Screening and baseline visits,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

Interventions

Tixel C DEVICE

Tixel C by 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.

Tixel Group

LipiFlow DEVICE

Thermal pulsation (LipiFlow) consists of the localized application of heat and therapeutic pressure on the four eyelids (upper and lower) with the aim of improving drainage of the Meibomian glands.

LipiFlow

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novoxel Ltd.: lead

Study Sites (5)

Gordon Schanzlin New Vision Institute

La Jolla, California, 92037, United States

Location

Visionary Research Institute

Newport Beach, California, 92663, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

PNV Clinical Research, LLC

Texas City, Texas, 78229, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Dr. Ifat Klein
• Organization: Novoxel Ltd

ifat@novoxel.com

+972-52-6009860

Study Officials

• Gregg Berdy, MD

  Ophthalmology Associates 12990 Manchester Rd., Ste. 200 St. Louis, MO 63131 314-966-3377

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded Evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Masked (Evaluator), Controlled, Prospective, open label study.

Study Record Dates

• First Submitted: November 21, 2021
• First Posted: December 17, 2021
• Study Start: September 19, 2022
• Primary Completion: April 26, 2023
• Study Completion: September 28, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Locations

US (5)