Status:
COMPLETED
Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction
Lead Sponsor:
Novoxel Ltd.
Conditions:
Dry Eye Syndromes
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 to initial treatment or plans for such treatment during the course treatment, or before complete healing of such treatments has occurred.
- Any patient who takes or has taken any oral or topical medications, herbal treatment, food supplements, or vitamins which may cause fragile skin or impaired skin healing during the last 3 months.
- Any patient who has a history of bleeding coagulopathies.
- Any patient who has tattoos or permanent makeup in the treated area.
- Any patient who has burned, blistered, irritated or sensitive skin in any of the areas to be treated.
- Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
- Individuals that were treated in either eye with LipiFlow in the last 24 months, or Tixel at any point in the past.
- Treatment in either eye with IPL in the last year.
- Expression of the meibomian glands within 6 months prior to screening.
- Use of at home warm compresses or lid hygiene products while participating in study.
Key Trial Info
Start Date :
October 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04889950
Start Date
October 26 2021
End Date
February 8 2023
Last Update
November 15 2024
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102