N/A
N=21
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
Bottom Line
View on ClinicalTrials.gov: NCT04889950 ↗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
| Outcome | Result | p-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
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.