Trial Outcomes & Findings for to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction (NCT NCT05162261)
NCT ID: NCT05162261
Last Updated: 2025-01-22
Results Overview
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
COMPLETED
NA
109 participants
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).
2025-01-22
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Tixel Group
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.
Tixel C: 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.
|
LipiFlow
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.
LipiFlow: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
54 108
|
55 110
|
|
Overall Study
COMPLETED
|
45 90
|
53 106
|
|
Overall Study
NOT COMPLETED
|
9 18
|
2 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
Tixel Group
n=54 Participants
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.
Tixel C: 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.
|
LipiFlow
n=55 Participants
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.
LipiFlow: 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.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
55 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 2
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 3
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 4
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 5
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ftzpatrick skin type
Type 6
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).Population: 48 Tixel subjects and 52 LipiFlow subjects completed the Baseline and 4-week FU TBUT examination.
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
Outcome measures
| Measure |
Tixel Group
n=96 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=104 Eyes
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.
LipiFlow: 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
Baseline
|
4.3 seconds
Standard Deviation 1.5
|
4.6 seconds
Standard Deviation 1.8
|
|
Changes in Tear Break Up Times (TBUT) to the 4-weeks Follow-up Exam
change from baseline - 4 weeks FU
|
3.0 seconds
Standard Deviation 3.2
|
2.7 seconds
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 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).Population: Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population
Comparison of the incidence of device-related Ocular adverse events for the two treatment arms
Outcome measures
| Measure |
Tixel Group
n=106 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=106 Eyes
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.
LipiFlow: 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.
|
|---|---|---|
|
Comparison of the Incidence of Device-related Ocular Adverse Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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).Population: Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses.Tixel subects and lipiflow subjects completed baseline, 4 weeks OSDI and 12 weeks 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
Outcome measures
| Measure |
Tixel Group
n=96 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=104 Eyes
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.
LipiFlow: 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 Patient OSDI
Baseline
|
50.2 score on a scale
Standard Deviation 18.3
|
49.4 score on a scale
Standard Deviation 15.5
|
|
Changes in Patient OSDI
Change 1 month - Baseline
|
-26.4 score on a scale
Standard Deviation 21.1
|
-18.8 score on a scale
Standard Deviation 21.0
|
|
Changes in Patient OSDI
Change 3 months - Baseline
|
-28.6 score on a scale
Standard Deviation 22.4
|
-21.9 score on a scale
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 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).Population: Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses.
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
Outcome measures
| Measure |
Tixel Group
n=90 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=104 Eyes
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.
LipiFlow: 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 12-weeks Follow-up Exam
Baseline
|
4.3 seconds
Standard Deviation 1.5
|
4.6 seconds
Standard Deviation 1.8
|
|
Changes in Tear Break Up Times (TBUT) to the 12-weeks Follow-up Exam
TBUT change from baseline to 12 weeks FU
|
3.1 seconds
Standard Deviation 4.3
|
3.3 seconds
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 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).Population: Per Protocol (PP) Population: Included all subjects who completed all study treatments as randomized, completed the 4-week follow-up visit, and who had no major protocol deviations. The PP population was used for the effectiveness endpoint analyses. subject in the tixel group and subject in the lipiflow group comparisoon at baseline, 4 weeks and 12 weeks visits.
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.
Outcome measures
| Measure |
Tixel Group
n=96 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=104 Eyes
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.
LipiFlow: 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 MGS to 4-weeks and 12-weeks Follow-up Exam
Baeline
|
7.2 score on a scale
Standard Deviation 2.5
|
7.4 score on a scale
Standard Deviation 2.6
|
|
Changes in MGS to 4-weeks and 12-weeks Follow-up Exam
Change 1 Month- Baseline
|
9.0 score on a scale
Standard Deviation 10.4
|
7.3 score on a scale
Standard Deviation 8.8
|
|
Changes in MGS to 4-weeks and 12-weeks Follow-up Exam
Change 3 Months - Baseline
|
11.3 score on a scale
Standard Deviation 11.4
|
10.5 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 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)Population: Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population
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
Outcome measures
| Measure |
Tixel Group
n=106 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=106 Eyes
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.
LipiFlow: 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.
|
|---|---|---|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort Treatment 1 -OD
|
2.8 score on a scale
Standard Deviation 1.9
|
1.5 score on a scale
Standard Deviation 1.6
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort Treatment 1 -OS
|
2.6 score on a scale
Standard Deviation 1.8
|
1.7 score on a scale
Standard Deviation 2.1
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort Treatment 2 - OD
|
2.7 score on a scale
Standard Deviation 1.8
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort Treatment 2 - OS
|
2.6 score on a scale
Standard Deviation 1.7
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort treatment 3 -OD
|
2.5 score on a scale
Standard Deviation 2.0
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Discomfort treatment 3 -OS
|
2.5 score on a scale
Standard Deviation 2.0
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain- Treatment 1 -OD
|
2.5 score on a scale
Standard Deviation 1.9
|
0.8 score on a scale
Standard Deviation 1.2
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain- Treatment 1-OS
|
2.5 score on a scale
Standard Deviation 1.9
|
0.9 score on a scale
Standard Deviation 1.5
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain - Treatment 2 -OD
|
2.5 score on a scale
Standard Deviation 1.9
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain - Treatment 2- OS
|
2.3 score on a scale
Standard Deviation 1.8
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain - Treatment 3 -OD
|
2.2 score on a scale
Standard Deviation 2.0
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
Pain - Treatment 3 -OS
|
2.2 score on a scale
Standard Deviation 1.9
|
—
|
SECONDARY outcome
Timeframe: 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).Population: Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population
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.
Outcome measures
| Measure |
Tixel Group
n=106 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=106 Eyes
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.
LipiFlow: 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.
|
|---|---|---|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Baseline
|
3.1 score on a scale
Standard Deviation 2.4
|
2.9 score on a scale
Standard Deviation 2.2
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Post Treatment 1
|
2.1 score on a scale
Standard Deviation 2.1
|
2.0 score on a scale
Standard Deviation 1.9
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Post Treatment 2
|
1.4 score on a scale
Standard Deviation 1.6
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Post Treatment 3
|
0.9 score on a scale
Standard Deviation 1.3
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
1 Month Follow-up
|
1.2 score on a scale
Standard Deviation 1.9
|
1.5 score on a scale
Standard Deviation 1.6
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
3 Months Follow up
|
1.3 score on a scale
Standard Deviation 2.2
|
1.3 score on a scale
Standard Deviation 1.8
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Change 1 Month - Baseline
|
-1.9 score on a scale
Standard Deviation 2.3
|
-1.4 score on a scale
Standard Deviation 2.2
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Change 3 Months - Baseline
|
-1.7 score on a scale
Standard Deviation 2.3
|
-1.6 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 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).Population: Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population
Changes from baseline following treatment for the test and control devices for: Intraocular Pressure
Outcome measures
| Measure |
Tixel Group
n=106 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=106 Eyes
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.
LipiFlow: 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.
|
|---|---|---|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Baseline
|
13.3 score on a scale
Standard Deviation 2.4
|
13.5 score on a scale
Standard Deviation 2.8
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Change in IOP (mmHG) from Baseline to 1 month follow up
|
0.4 score on a scale
Standard Deviation 2.5
|
0.2 score on a scale
Standard Deviation 2.5
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
change in IOP (mmHG) from Baseline to 3 months follow up
|
0.1 score on a scale
Standard Deviation 2.7
|
0.3 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 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).Population: Safety Population: Included all subjects who were treated. All safety analyses were performed using the Safety population
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.
Outcome measures
| Measure |
Tixel Group
n=106 Eyes
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.
Tixel C: 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.
|
LipiFlow
n=106 Eyes
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.
LipiFlow: 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.
|
|---|---|---|
|
Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline
Basline
|
2.4 score on a scale
Standard Deviation 2.8
|
2.4 score on a scale
Standard Deviation 2.5
|
|
Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline
Change from baseline to 1 month FU
|
-0.9 score on a scale
Standard Deviation 2.3
|
-1.2 score on a scale
Standard Deviation 2.7
|
|
Ocular Surface Conjunctival Lissamine Green Staining Changes From Baseline
Change from baseline to 3 months FU
|
-1.3 score on a scale
Standard Deviation 2.7
|
-1.2 score on a scale
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 months post-last treatment (7 months post-baseline)Population: Tixel sub-group population
Durability of the clinical benefit effect at 6-months FU visit assessed by OSDI parameter for a Tixel sub-group population only.
Outcome measures
| Measure |
Tixel Group
n=42 Eyes
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.
Tixel C: 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.
|
LipiFlow
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.
LipiFlow: 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.
|
|---|---|---|
|
Extension Study Endpoint 1
Baseline
|
46.2 score on a scale
Standard Deviation 19.7
|
—
|
|
Extension Study Endpoint 1
6 months FU visit
|
21.9 score on a scale
Standard Deviation 19.4
|
—
|
|
Extension Study Endpoint 1
6 months FU score change from baseline
|
-24.3 score on a scale
Standard Deviation 26.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 months post-last treatment (7 months post-baseline)Population: Tixel sub-group population
Durability of the clinical benefit effect at 6-months FU visit assessed by TBUT parameter for a Tixel sub-group population only.
Outcome measures
| Measure |
Tixel Group
n=42 Eyes
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.
Tixel C: 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.
|
LipiFlow
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.
LipiFlow: 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.
|
|---|---|---|
|
Extension Study Endpoint 2
Baseline
|
4.0 seconds
Standard Deviation 1.5
|
—
|
|
Extension Study Endpoint 2
6 months FU visit
|
9.2 seconds
Standard Deviation 4.0
|
—
|
|
Extension Study Endpoint 2
change from baseline - 6 months FU visit
|
5.2 seconds
Standard Deviation 3.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 months post-last treatment (7 months post-baseline)Population: Tixel sub-group population
Durability of the clinical benefit effect at 6-months FU visit assessed by MGSS parameter for a Tixel sub-group population only.
Outcome measures
| Measure |
Tixel Group
n=42 Eyes
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.
Tixel C: 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.
|
LipiFlow
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.
LipiFlow: 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.
|
|---|---|---|
|
Extension Study Endpoint 3
Baseline
|
6.6 score on a scale
Standard Deviation 2.3
|
—
|
|
Extension Study Endpoint 3
6 months FU visit
|
24.8 score on a scale
Standard Deviation 10.9
|
—
|
|
Extension Study Endpoint 3
change from baseline at 6 months FU visit
|
18.2 score on a scale
Standard Deviation 10.9
|
—
|
Adverse Events
Tixel Group
LipiFlow
Serious adverse events
| Measure |
Tixel Group
n=53 participants at risk
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.
Tixel C: 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.
|
LipiFlow
n=53 participants at risk
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.
LipiFlow: 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.
|
|---|---|---|
|
Eye disorders
Retinal Detachment
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Eye disorders
Operculated Retinal Hole
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
facial melanoma in situ
|
0.00%
0/53 • 12 months and 10 days
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Infections and infestations
Infectious L5/S1 spondylodiscitis
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
Other adverse events
| Measure |
Tixel Group
n=53 participants at risk
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.
Tixel C: 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.
|
LipiFlow
n=53 participants at risk
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.
LipiFlow: 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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal mass
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Infections and infestations
Bronchitis
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Infections and infestations
COVID-19
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Vascular disorders
Hyprtension
|
0.00%
0/53 • 12 months and 10 days
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
|
Infections and infestations
Mastoiditis
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/53 • 12 months and 10 days
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/53 • 12 months and 10 days
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/53 • 12 months and 10 days
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
|
Infections and infestations
Conjunctivitis viral
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
1.9%
1/53 • Number of events 1 • 12 months and 10 days
|
0.00%
0/53 • 12 months and 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER