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
Randomized, open-label study comparing the Tixel device to LipiFlow System. Up to 110 patients (220 eyes) to be randomized in up to 5 clinical sites in the United States. Evaluators will be masked as to the randomization assignments. Both eyes will receive the same randomized assignment and both eyes of each patient will be evaluated at all time points. Data from both eyes will be using in the statistical analysis. The random-effects model adjusts the standard error (SE) and the confidence interval (CI) for within-person correlation between eyes. Protocol Rev. 7.0 update: Addition of protocol extension to the current protocol: stage 1- main protocol for all patients and stage 2- extension protocol to a sub-group of patients only in the Tixel arm for additional follow-up visit 6 months post last treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
109
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.
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.
Gordon Schanzlin New Vision Institute
La Jolla, California, United States
Visionary Research Institute
Newport Beach, California, United States
Moyes Eye Center
Kansas City, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
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
Time frame: 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
Time frame: 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 Patient 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 1. Some of the time 2. Half of the time 3. Most of the time 4. 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
Time frame: 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).
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PNV Clinical Research, LLC
Texas City, Texas, United States
Changes in Tear Break Up Times (TBUT) to the 12-weeks Follow-up Exam
Changes from baseline to the 12-weeks follow-up exam in Tear Break Up Times (TBUT), as assessed by a masked rater. BUT - 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
Time frame: 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
score on a scale at baseline, 4-weeks and 12-weeks follow-up exam in Meibomian Gland (MGS), as assessed by a masked rater. The Meibomian Gland Score (MGS) is a clinical tool used to evaluate the function of the meibomian glands. Scoring Criteria Each gland is assessed and scored based on the quality of the expressed secretion: 0: No secretion 1. Inspissated 2. Cloudy 3. Clear liquid Interpretation of MGS Minimal MGS score = 0 in each eye (15 glands evaluated in each eye) Maximal MGS score = 45 in each eye (15 glands evaluated in each eye) Low MGS: (below 12) Indicates poor function or obstruction of the meibomian glands, suggesting MGD.
Time frame: 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)
Discomfort and Pain from the treatment (Tixel or LipiFlow) using the questionnaires assessed by the subject. These are visual analogue scale (VAS) questionnaires using a scale from 0-10 to assess eye discomfort and pain. Both questionnaires are to be self-assessed by the patient immediately following treatment. Interpetation for the assessment: score 0- no discomfort / pain score 5 - moderate discomfort / pain score 10 - worst possible discomfort / pain
Time frame: 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
Changes from baseline following treatment for the test and control devices for the following assessments: Ocular Surface Staining (to evaluate the integrity of the corneal epithelium by identifying areas of damage or staining) Grading scale: 0 = Normal - No staining 1. = Mild - Superficial stippling micropunctate staining 2. = Moderate - Macropunctate staining with some coalescent areas 3. = Severe - Numerous coalescent macropunctate areas and/or patches 5 regions (superior, temporal, central, nasal, and inferior) are graded for each eye. total score range from 0 -15.
Time frame: 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).
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Changes from baseline following treatment for the test and control devices for: Intraocular Pressure
Time frame: 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).
Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline
Changes from baseline following treatment for the test and control devices for the following assessments: Lissamine staining scores (to assess the health of the conjunctival and corneal epithelium, particularly in dry eye disease, by identifying areas of damaged or dead cells). Grading scale: 0 = Normal - No staining 1. = Mild - Superficial stippling micropunctate staining 2. = Moderate - Macropunctate staining with some coalescent areas 3. = Severe - Numerous coalescent macropunctate areas and/or patches 6 regions (nasal, superior nasal, inferior nasal, temporal, superior temporal, inferior temporal) are graded for each eye. The total score range for each eye is 0-18.
Time frame: 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).