Exploratory Clinical Study to Evaluate the Efficacy and Safety of Tixel C for the Treatment of Myoblast Dysfunction

JRCT ID: jRCTs032220286

Registered date:22/08/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Meibomian gland dysfunction
• Date of first enrollment: 10/09/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Treatment of Tixel C

Outcome(s)

• Primary Outcome: Change from baseline to the the 4-weeks follow-up exam in Tear Break Up Time (TBUT)
• Secondary Outcome: Change from baseline to the the 4-weeks follow-up exam in Ocular Surface Disease Index(OSDI)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

It is intended for patients who meet all of the following criteria.
(1) Age 18 years and older of any gender or race.
(2) Provision of written informed consent prior to study participation.
(3) Patients who are participating in the study and can undergo all the treatments and tests prescribed in the protocol.
(4) Patients with dry eye symptoms in 3 months prior to obtaining consent and the Ocular Surface Disease Index (OSDI) questionnaire score of 23 or higher after obtaining consent.
(5) Patients with Tear Layer Breakdown Time (TBUT) of less than 10 seconds.
(6) 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 and already used prior to the study.)
(7) Fitzpatrick skin type I-VI

Exclude criteria

Patients who is applicable those followings to be excluded.
(1) History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year.
(2) Patients with giant papillary conjunctivitis.
(3) Patients with punctal plugs or who have had punctal cautery.
(4) Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of obtaining consent.
(5) Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months of obtaining consent.
(6) Patients who are aphakic.
(7) Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
(8) 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).
(9) Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months of obtaining consent (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis).
(10) 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).
(11) Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that may affect lid function in either eye.
(12) Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4).
(13) Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren syndrome).
(14) Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
(15) Women in child baring age who are pregnant, nursing, or not utilizing adequate birth control measures.
(16) Individuals who have changed the dosing of either systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to obtaining consent.
(17) Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study.
(18) Patients who have taken dry eye or MGD medications (antibiotics, nonsteroidal anti-inflammatory drugs, adrenal corticoster hormones) for at least two weeks or more within one year prior to obtaining consent. (Ocular lubricants are allowed if no changes are made during the study).
(19) Individuals wearing contact lenses at any time during the prior three months and at any point during the study.
(20) Current skin cancer, malignant sites and/or advanced premalignant lesions or moles in the treatment area.
(21) An impaired immune system condition or use of immunosuppressive medication.
(22) Keloid formation and/or abnormal wound healing.
(23) Patients who have received laser irradiation treatment at the treatment site for 3 months prior to the first treatment or require such treatment before the end of the study, or patients who have performed such treatment in the past.
(24) 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 of obtaining consent.
(25) Any patient who has a history of bleeding coagulopathies.
(26) Any patient who has tattoos or permanent makeup in the treated area.
(27) Any patient who has burned, blistered, irritated or sensitive skin in any of the areas to be treated.
(28) Individuals using another ophthalmic investigational device or agent within 30 days of study participation.
(29) Individuals that were treated in either eye with Tixel C at any point in the past.
(30) Treatment in either eye with IPL or other thermal treatment (LipiFlow, i-Lux etc) in the last year.
(31) Patients who were considered as ineligible by the investigator for safety or poor protocol compliance.

Related Information

• Primary Sponsor: Yuichi Hori
• Secondary Sponsor: Novoxel Japan K.K.