An interventional study of Tixel C and LipiFlow in Meibomian Gland Dysfunction, Dry Eye Syndromes and Dry Eye, sponsored by Novoxel Ltd.. Completed at 5 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Novoxel Ltd. · Not applicable, Interventional, and Treatment
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's enrollment of 109 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Novoxel Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Study (Stage1) Inclusion Criteria:
Main Study (Stage1) Exclusion Criteria:
Use of any of the following medications:
Any of the following dry eye treatments:
Study Extension (Stage 2)- Inclusion Criteria
Study Extension (Stage 2)-Exclusion Criteria
* Same as in the main study (stage 1).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Screening and baseline visits, Treatment- 3 treatment sessions, 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: Tixel C
LipiFlow: Screening and baseline visits,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 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.
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).
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).
Extension Study Endpoint 1
Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter for a Tixel sub-group population only.
Time frame: Baseline and 6 months post-last treatment (7 months post-baseline)
Extension Study Endpoint 2
Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter for a Tixel sub-group population only.
Time frame: Baseline and 6 months post-last treatment (7 months post-baseline)
Extension Study Endpoint 3
Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter for a Tixel sub-group population only.
Time frame: Baseline and 6 months post-last treatment (7 months post-baseline)
| Milestone | Tixel Group | LipiFlow |
|---|---|---|
| Started | 54 | 55 |
| Completed | 45 | 53 |
| Not completed | 9 | 2 |
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 |
|---|---|---|
| Baseline | 4.3 ± 1.5 | 4.6 ± 1.8 |
| change from baseline - 4 weeks FU | 3.0 ± 3.2 | 2.7 ± 2.7 |
Comparison of the incidence of device-related Ocular adverse events for the two treatment arms
| participants | Tixel Group | LipiFlow |
|---|---|---|
| Comparison of the Incidence of Device-related Ocular Adverse Events | 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 |
|---|---|---|
| Baseline | 50.2 ± 18.3 | 49.4 ± 15.5 |
| Change 1 month - Baseline | -26.4 ± 21.1 | -18.8 ± 21.0 |
| Change 3 months - Baseline | -28.6 ± 22.4 | -21.9 ± 18.5 |
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 |
|---|---|---|
| Baseline | 4.3 ± 1.5 | 4.6 ± 1.8 |
| TBUT change from baseline to 12 weeks FU | 3.1 ± 4.3 | 3.3 ± 3.6 |
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 |
|---|---|---|
| Baeline | 7.2 ± 2.5 | 7.4 ± 2.6 |
| Change 1 Month- Baseline | 9.0 ± 10.4 | 7.3 ± 8.8 |
| Change 3 Months - Baseline | 11.3 ± 11.4 | 10.5 ± 12.2 |
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 |
|---|---|---|
| Discomfort Treatment 1 -OD | 2.8 ± 1.9 | 1.5 ± 1.6 |
| Discomfort Treatment 1 -OS | 2.6 ± 1.8 | 1.7 ± 2.1 |
| Discomfort Treatment 2 - OD | 2.7 ± 1.8 | — |
| Discomfort Treatment 2 - OS | 2.6 ± 1.7 | — |
| Discomfort treatment 3 -OD | 2.5 ± 2.0 | — |
| Discomfort treatment 3 -OS | 2.5 ± 2.0 | — |
| Pain- Treatment 1 -OD | 2.5 ± 1.9 | 0.8 ± 1.2 |
| Pain- Treatment 1-OS | 2.5 ± 1.9 | 0.9 ± 1.5 |
| Pain - Treatment 2 -OD | 2.5 ± 1.9 | — |
| Pain - Treatment 2- OS | 2.3 ± 1.8 | — |
| Pain - Treatment 3 -OD | 2.2 ± 2.0 | — |
| Pain - Treatment 3 -OS | 2.2 ± 1.9 | — |
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 | 3.1 ± 2.4 | 2.9 ± 2.2 |
| Post Treatment 1 | 2.1 ± 2.1 | 2.0 ± 1.9 |
| Post Treatment 2 | 1.4 ± 1.6 | — |
| Post Treatment 3 | 0.9 ± 1.3 | — |
| 1 Month Follow-up | 1.2 ± 1.9 | 1.5 ± 1.6 |
| 3 Months Follow up | 1.3 ± 2.2 | 1.3 ± 1.8 |
| Change 1 Month - Baseline | -1.9 ± 2.3 | -1.4 ± 2.2 |
| Change 3 Months - Baseline | -1.7 ± 2.3 | -1.6 ± 2.1 |
Changes from baseline following treatment for the test and control devices for: Intraocular Pressure
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| Baseline | 13.3 ± 2.4 | 13.5 ± 2.8 |
| Change in IOP (mmHG) from Baseline to 1 month follow up | 0.4 ± 2.5 | 0.2 ± 2.5 |
| change in IOP (mmHG) from Baseline to 3 months follow up | 0.1 ± 2.7 | 0.3 ± 2.4 |
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.
| score on a scale | Tixel Group | LipiFlow |
|---|---|---|
| Basline | 2.4 ± 2.8 | 2.4 ± 2.5 |
| Change from baseline to 1 month FU | -0.9 ± 2.3 | -1.2 ± 2.7 |
| Change from baseline to 3 months FU | -1.3 ± 2.7 | -1.2 ± 3.0 |
Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter for a Tixel sub-group population only.
| score on a scale | Tixel Group |
|---|---|
| Baseline | 46.2 ± 19.7 |
| 6 months FU visit | 21.9 ± 19.4 |
| 6 months FU score change from baseline | -24.3 ± 26.5 |
Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter for a Tixel sub-group population only.
| seconds | Tixel Group |
|---|---|
| Baseline | 4.0 ± 1.5 |
| 6 months FU visit | 9.2 ± 4.0 |
| change from baseline - 6 months FU visit | 5.2 ± 3.8 |
Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter for a Tixel sub-group population only.
| score on a scale | Tixel Group |
|---|---|
| Baseline | 6.6 ± 2.3 |
| 6 months FU visit | 24.8 ± 10.9 |
| change from baseline at 6 months FU visit | 18.2 ± 10.9 |
Collected over 12 months and 10 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tixel Group | 0/53 (0%) | 4/53 (7.5%) | 6/53 (11.3%) |
| LipiFlow | 0/53 (0%) | 1/53 (1.9%) | 4/53 (7.5%) |
| Event | Tixel Group | LipiFlow |
|---|---|---|
| Retinal DetachmentEye disorders | 1/53 | 0/53 |
| Operculated Retinal HoleEye disorders | 1/53 | 0/53 |
| facial melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/53 | 1/53 |
| SepsisInfections and infestations | 1/53 | 0/53 |
| Infectious L5/S1 spondylodiscitisInfections and infestations | 1/53 | 0/53 |
| Event | Tixel Group | LipiFlow |
|---|---|---|
| Abdominal massGastrointestinal disorders | 1/53 | 0/53 |
| BronchitisInfections and infestations | 1/53 | 0/53 |
| COVID-19Infections and infestations | 1/53 | 0/53 |
| HyprtensionVascular disorders | 0/53 | 1/53 |
| MastoiditisInfections and infestations | 1/53 | 0/53 |
| VertigoEar and labyrinth disorders | 0/53 | 1/53 |
| Conjunctival cystEye disorders | 0/53 | 1/53 |
| Conjunctivitis allergicEye disorders | 0/53 | 1/53 |
| Conjunctivitis viralInfections and infestations | 1/53 | 0/53 |
| Corneal abrasionInjury, poisoning and procedural complications | 1/53 | 0/53 |
The intent-to-treat (ITT) population includes all randomized subjects. Subjects were analyzed as randomized.
| Age, Continuous(years) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Mean | 61.9 ± 12.4 | 61.7 ± 12.8 | 61.8 ± 12.6 |
| Sex: Female, Male(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Female | 37 | 35 | 72 |
| Male | 17 | 20 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 49 | 50 | 99 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 1 | 2 |
| White | 50 | 51 | 101 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| United States | 54 | 55 | 109 |
| Ftzpatrick skin type(Participants) | Tixel Group | LipiFlow | Total |
|---|---|---|---|
| Type 1 | 1 | 1 | 2 |
| Type 2 | 18 | 17 | 35 |
| Type 3 | 15 | 21 | 36 |
| Type 4 | 16 | 13 | 29 |
| Type 5 | 3 | 2 | 5 |
| Type 6 | 1 | 1 | 2 |
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