Evaluate the Safety and Effectiveness of The Tixel Fracti... | NCT04889950

NCT04889950

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tixel Group	Experimental	Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after 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- 1 single 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

Name	Type	Description	Arm Group Labels	Other Names
Tixel C	Device	Tixel C )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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater	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 Adverse Events for the Two-treatment Arms.	Comparison of the incidence of device-related adverse events (e.g., increase in the lid margin such as development of floppy eyelids, entropion or ectropion; and lash integrity) 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

Measure	Description	Time Frame
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).	Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam. The Ocular Surface Disease Index (OSDI) is a questionnaire designed to assess the severity of dry eye disease. OSDI Questionnaire The questionnaire consists of 12 questions divided into three subscales: Ocular Symptoms Visual Functioning Environmental Triggers Scoring System The scoring for the OSDI is based on a scale from 0 to 100, where higher scores indicate more severe symptoms. Each question is scored as follows: 0: None of the time Some of the time Half of the time Most of the time All of the time Interpretation of OSDI Scores The OSDI scores are generally interpreted as follows: 0-12: Normal or no dry eye 13-22: Mild dry eye 23-32: Moderate dry eye 33-100: Severe dry eye

Eligibility Module

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 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.

Name	Affiliation	Role
Ehud Reich, MD	Shaare Zedek Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center		Jerusalem		9103102	Israel

Arm/Group Information

ID	Title	Description
FG000	Tixel Group	Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. Tixel C: Tixel C (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.
FG001	LipiFlow	LipiFlow: Screening and baseline visits, Treatment- 1 single 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. LipiFlow: LipiFlow

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Tixel Group	Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. Tixel C: Tixel C )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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater

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

10 Tixel subjects and 10 LipiFlow subjects completed the Baseline and 4-week FU TBUT examination.

Posted

Mean

95% Confidence Interval

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).

Eyes

ID	Title	Description

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tixel Group	Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire. Tixel C: Tixel C )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.

ID	Term
D015352	Dry Eye Syndromes
D000080343	Meibomian Gland Dysfunction

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D005141	Eyelid Diseases