An interventional study of Tixel C and LipiFlow in Dry Eye Syndromes, Dry Eye and Meibomian Gland Dysfunction, sponsored by Novoxel Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment
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.
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 Dysfunction (MGD). study subject will receive three (3) treatments with Tixel in a monthly interval, and single treatment for the control group. Follow-up will occur 1 month and 3 months following the last treatment.
Tixel group study visits will be as follow:
Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatments - three treatments will be conducted to the study device group. Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last treatment.
Control group visit will be as follow:
Screening: (Must be done up to 7 days prior to initial treatment (Day 0), but can be also done on the same day as baseline testing and initial treatment) Randomization: (Performed after determining that patient is eligible for the study) Treatment- single Follow-Up Visits: 4-Weeks (+/-7days) and 12-Weeks (+/-14 days) after last treatment.
Exclusion Criteria:
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: 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
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.
LipiFlow
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
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 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.
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 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 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).
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
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).
Overall Changes From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater.
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).
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
the IOP values changes from baseline, respectively, for all visits, per treatment arm.
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).
Lissamine Green Staining Scores and the 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. 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).
| Milestone | Tixel Group | LipiFlow |
|---|---|---|
| Started | 11 | 10 |
| Completed | 9 | 10 |
| Not completed | 2 | 0 |
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
| seconds | Tixel Group | LipiFlow |
|---|---|---|
| 4 weeks change from baseline | 4.0 (2.3 to 5.6) | 1.9 (0.8 to 3.0) |
| Baseline score | 3.4 (3.1 to 3.7) | 4.7 (3.9 to 5.4) |
| 4 weeks FU score | 7.4 (5.8 to 9.1) | 6.6 (5.3 to 7.8) |
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.
| number of events | Tixel Group | LipiFlow |
|---|---|---|
| Comparison of the Incidence of Device-related Adverse Events for the Two-treatment Arms. | 0 | 0 |
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
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| OSDI at Baseline | 42.7 (30.4 to 55.0) | 47.6 (33.8 to 61.4) |
| OSDI at 4 weeks | 22.0 (10.0 to 34.0) | 38.2 (19.2 to 57.3) |
| OSDI at 12 weeks | 27.0 (10.7 to 43.3) | 32.4 (17.1 to 47.8) |
| change from baseline to 4 weeks | -20.7 (-25.5 to -15.9) | -9.4 (-22.7 to 3.9) |
| change from baseline at 12 weeks FU | -15.4 (-27.4 to -3.4) | -15.2 (-28.4 to -1.9) |
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.
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| MGS at baseline | 2.5 (1.0 to 4.0) | 4.5 (2.9 to 6.1) |
| MGS at 4 weeks | 13.7 (7.6 to 19.7) | 5.6 (3.0 to 8.2) |
| MGS at 12 weeks | 9.8 (4.5 to 15.1) | 13.9 (9.0 to 18.7) |
| 4 weeks MGS Change from Baseline | 11.2 (5.3 to 17.0) | 1.1 (-1.6 to 3.8) |
| 12 weeks MGS Change from Baseline | 7.1 (1.4 to 12.8) | 9.4 (4.8 to 13.9) |
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
| seconds | Tixel Group | LipiFlow |
|---|---|---|
| Overall Changes From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater. | 4.2 ± 2.9 | 1.6 ± 2.2 |
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
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| post Treatment 1 pain score | 3.9 (2.6 to 5.3) | 0.5 (0.1 to 1.0) |
| post Treatment 2 pain score | 3.6 (2.6 to 4.6) | — |
| post Treatment 3 pain score | 2.8 (2.2 to 3.4) | — |
| post Treatment 1 discomfort score | 3.7 (2.5 to 4.9) | 0.9 (0.2 to 1.5) |
| post Treatment 2 discomfort score | 3.6 (2.5 to 4.7) | — |
| post Treatment 3 discomfort score | 3.6 (2.7 to 4.4) | — |
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.
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| Baseline score | 6.6 (4.9 to 8.4) | 3.6 (1.8 to 5.3) |
| Treatment 1 score | 6.6 (4.9 to 8.3) | 3.6 (2.1 to 5.1) |
| treatment 2 score | 2.0 (1.1 to 2.8) | — |
| treatment 3 score | 1.2 (0.4 to 1.9) | — |
| 4 weeks FU score | 2.1 (0.7 to 3.4) | 2.4 (1.5 to 3.3) |
| 12 weeks FU score | 2.0 (1.1 to 2.9) | 1.8 (0.5 to 3.1) |
| Treatment 1 change from baseline | -0.0 (-1.0 to 0.9) | 0.1 (-1.5 to 1.6) |
| Treatment 2 change from baseline | -4.3 (-6.0 to -2.5) | — |
| Treatment 3 change from baseline | -5.1 (-6.4 to -3.7) | — |
| 4 weeks FU change from baseline | -4.2 (-5.9 to -2.4) | -1.2 (-3.0 to 0.7) |
| 12 weeks FU change from baseline | -3.8 (-5.6 to -1.9) | -1.8 (-2.7 to -0.8) |
the IOP values changes from baseline, respectively, for all visits, per treatment arm.
| mmHg | Tixel Group | LipiFlow |
|---|---|---|
| Treatment 1 | -0.3 ± 3.0 | -3.3 ± 2.2 |
| Treament 2 | -1.5 ± 2.5 | — |
| Treatment 3 | -1.5 ± 2.0 | — |
| 4 weeks FU | 0.2 ± 2.8 | -0.1 ± 2.0 |
| 12 weeks FU | 0.4 ± 2.3 | 1.5 ± 2.1 |
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. total score range for each eye is 0-18.
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| Baseline | 6.1 (5.0 to 7.3) | 4.7 (3.4 to 6.0) |
| Treatment 1 | 5.4 (4.0 to 6.8) | 3.1 (2.0 to 4.1) |
| Treatment 2 | 1.5 (0.7 to 2.2) | — |
| Treatment 3 | 1.0 (0.2 to 1.8) | — |
| 4 weeks FU | 1.4 (0.4 to 2.3) | 3.3 (2.2 to 4.4) |
| 12 weeks FU | 1.9 (0.7 to 3.0) | 1.5 (0.4 to 2.6) |
| Treatment 1 change from baseline | -0.7 (-1.5 to 0.0) | -1.7 (-2.7 to -0.6) |
| Treatment 2 change from baseline | -4.9 (-6.2 to -3.6) | — |
| Treatment 3 change from baseline | -5.4 (-6.7 to -4.0) | — |
| FU 4 weeks change from baseline | -5.0 (-6.4 to -3.6) | -1.4 (-3.0 to 0.2) |
| FU 12 weeks change from baseline | -4.1 (-5.8 to -2.3) | -3.2 (-4.7 to -1.7) |
Collected over 15 months and 13 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tixel Group | 0/11 (0%) | 0/11 (0%) | 4/11 (36.4%) |
| LipiFlow | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Tixel Group | LipiFlow |
|---|---|---|
| COVID-19Infections and infestations | 1/11 | 2/10 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/11 | 1/10 |
| Conjunctival depositEye disorders | 1/11 | 0/10 |
| Corneal opacityEye disorders | 1/11 | 0/10 |
| Pulpitis dentalInfections and infestations | 1/11 | 0/10 |
| Conjunctival scarInjury, poisoning and procedural complications | 1/11 | 0/10 |
| MigraineNervous system disorders | 1/11 | 0/10 |
| Rash papularSkin and subcutaneous tissue disorders | 1/11 | 0/10 |
| ChalazionEye disorders | 1/11 | 0/10 |
study subjects comparing the Tixel device to LipiFlow System
| Age, Categorical(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 8 | 15 |
| >=65 years | 4 | 2 | 6 |
| Age, Continuous(years) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Mean | 57.5 ± 18.9 | 59.4 ± 7.7 | 58.4 ± 14.3 |
| Sex: Female, Male(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Female | 9 | 7 | 16 |
| Male | 2 | 3 | 5 |
| Race/Ethnicity, Customized(participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| caucasian | 11 | 8 | 19 |
| white | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Israel | 11 | 10 | 21 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novoxel Ltd.