Trial Outcomes & Findings for Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction (NCT NCT04889950)
NCT ID: NCT04889950
Last Updated: 2024-11-15
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 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).
Results posted on
2024-11-15
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
Tixel Group
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C (Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Overall Study
STARTED
|
11 22
|
10 20
|
|
Overall Study
COMPLETED
|
9 18
|
10 20
|
|
Overall Study
NOT COMPLETED
|
2 4
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Safety and Effectiveness of The Tixel Fractional System in the Treatment of Meibomian Gland Disfunction
Baseline characteristics by cohort
| Measure |
Tixel Group
n=11 Participants
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=10 Participants
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 18.9 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
caucasian
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 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: 10 Tixel subjects and 10 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=20 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
4 weeks change from baseline
|
4.0 seconds
Interval 2.3 to 5.6
|
1.9 seconds
Interval 0.8 to 3.0
|
|
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
Baseline score
|
3.4 seconds
Interval 3.1 to 3.7
|
4.7 seconds
Interval 3.9 to 5.4
|
|
Score and Change From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater
4 weeks FU score
|
7.4 seconds
Interval 5.8 to 9.1
|
6.6 seconds
Interval 5.3 to 7.8
|
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: Ae's observed in Tixel group compared to Lipiflow group
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.
Outcome measures
| Measure |
Tixel Group
n=11 Participants
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=10 Participants
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Comparison of the Incidence of Device-related Adverse Events for the Two-treatment Arms.
|
0 number of events
|
0 number of events
|
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: 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=20 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
OSDI at Baseline
|
42.7 score on a scale
Interval 30.4 to 55.0
|
47.6 score on a scale
Interval 33.8 to 61.4
|
|
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
OSDI at 4 weeks
|
22.0 score on a scale
Interval 10.0 to 34.0
|
38.2 score on a scale
Interval 19.2 to 57.3
|
|
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
OSDI at 12 weeks
|
27.0 score on a scale
Interval 10.7 to 43.3
|
32.4 score on a scale
Interval 17.1 to 47.8
|
|
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
change from baseline to 4 weeks
|
-20.7 score on a scale
Interval -25.5 to -15.9
|
-9.4 score on a scale
Interval -22.7 to 3.9
|
|
Score on a Scale and Change From Baseline in Patient Symptoms Using Ocular Surface Disease Index (OSDI).
change from baseline at 12 weeks FU
|
-15.4 score on a scale
Interval -27.4 to -3.4
|
-15.2 score on a scale
Interval -28.4 to -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: 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=20 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
MGS at baseline
|
2.5 score on a scale
Interval 1.0 to 4.0
|
4.5 score on a scale
Interval 2.9 to 6.1
|
|
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
MGS at 4 weeks
|
13.7 score on a scale
Interval 7.6 to 19.7
|
5.6 score on a scale
Interval 3.0 to 8.2
|
|
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
MGS at 12 weeks
|
9.8 score on a scale
Interval 4.5 to 15.1
|
13.9 score on a scale
Interval 9.0 to 18.7
|
|
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
4 weeks MGS Change from Baseline
|
11.2 score on a scale
Interval 5.3 to 17.0
|
1.1 score on a scale
Interval -1.6 to 3.8
|
|
Score on a Scale and Change From Baseline in Meibomian Gland Score (MGS), as Assessed by a Masked Rater.
12 weeks MGS Change from Baseline
|
7.1 score on a scale
Interval 1.4 to 12.8
|
9.4 score on a scale
Interval 4.8 to 13.9
|
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: 9 Tixel subjects and 10 LipiFlow subjects completed the 12-week FU TBUT examination.
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=18 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Overall Changes From Baseline in Tear Break Up Times (TBUT), as Assessed by a Masked Rater.
|
4.2 seconds
Standard Deviation 2.9
|
1.6 seconds
Standard Deviation 2.2
|
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: Post-Treatment Pain Questionnaire scores, by tixel and lipiflow groups
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=22 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 1 pain score
|
3.9 score on a scale
Interval 2.6 to 5.3
|
0.5 score on a scale
Interval 0.1 to 1.0
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 2 pain score
|
3.6 score on a scale
Interval 2.6 to 4.6
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 3 pain score
|
2.8 score on a scale
Interval 2.2 to 3.4
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 1 discomfort score
|
3.7 score on a scale
Interval 2.5 to 4.9
|
0.9 score on a scale
Interval 0.2 to 1.5
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 2 discomfort score
|
3.6 score on a scale
Interval 2.5 to 4.7
|
—
|
|
Score on a Scale During Treatment Discomfort and Pain Questionnaires (Each Self-assessed by VAS)
post Treatment 3 discomfort score
|
3.6 score on a scale
Interval 2.7 to 4.4
|
—
|
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: Corneal Fluorescein Staining Slit Lamp evaluation score (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=22 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Baseline score
|
6.6 score on a scale
Interval 4.9 to 8.4
|
3.6 score on a scale
Interval 1.8 to 5.3
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Treatment 1 score
|
6.6 score on a scale
Interval 4.9 to 8.3
|
3.6 score on a scale
Interval 2.1 to 5.1
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
treatment 2 score
|
2.0 score on a scale
Interval 1.1 to 2.8
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
treatment 3 score
|
1.2 score on a scale
Interval 0.4 to 1.9
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
4 weeks FU score
|
2.1 score on a scale
Interval 0.7 to 3.4
|
2.4 score on a scale
Interval 1.5 to 3.3
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
12 weeks FU score
|
2.0 score on a scale
Interval 1.1 to 2.9
|
1.8 score on a scale
Interval 0.5 to 3.1
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Treatment 1 change from baseline
|
-0.0 score on a scale
Interval -1.0 to 0.9
|
0.1 score on a scale
Interval -1.5 to 1.6
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Treatment 2 change from baseline
|
-4.3 score on a scale
Interval -6.0 to -2.5
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
Treatment 3 change from baseline
|
-5.1 score on a scale
Interval -6.4 to -3.7
|
—
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
4 weeks FU change from baseline
|
-4.2 score on a scale
Interval -5.9 to -2.4
|
-1.2 score on a scale
Interval -3.0 to 0.7
|
|
Corneal Fluorescein Staining Slit Lamp Evaluation Scores and Change From Baseline
12 weeks FU change from baseline
|
-3.8 score on a scale
Interval -5.6 to -1.9
|
-1.8 score on a scale
Interval -2.7 to -0.8
|
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: IOP values in mmHg and the changes from baseline to 12 weeks FU
the IOP values changes from baseline, respectively, for all visits, per treatment arm.
Outcome measures
| Measure |
Tixel Group
n=22 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Treatment 1
|
-0.3 mmHg
Standard Deviation 3.0
|
-3.3 mmHg
Standard Deviation 2.2
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Treament 2
|
-1.5 mmHg
Standard Deviation 2.5
|
—
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
Treatment 3
|
-1.5 mmHg
Standard Deviation 2.0
|
—
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
4 weeks FU
|
0.2 mmHg
Standard Deviation 2.8
|
-0.1 mmHg
Standard Deviation 2.0
|
|
The Mean Changes From Baseline in IOP for All Eyes on the Tixel and Lipiflow Arms
12 weeks FU
|
0.4 mmHg
Standard Deviation 2.3
|
1.5 mmHg
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: subjects performed Lissamine staining scoresat baseline and during study visits
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.
Outcome measures
| Measure |
Tixel Group
n=22 Eyes
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=20 Eyes
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Lissamine Green Staining Scores and the Changes From Baseline
Baseline
|
6.1 score on a scale
Interval 5.0 to 7.3
|
4.7 score on a scale
Interval 3.4 to 6.0
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 1
|
5.4 score on a scale
Interval 4.0 to 6.8
|
3.1 score on a scale
Interval 2.0 to 4.1
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 2
|
1.5 score on a scale
Interval 0.7 to 2.2
|
—
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 3
|
1.0 score on a scale
Interval 0.2 to 1.8
|
—
|
|
Lissamine Green Staining Scores and the Changes From Baseline
4 weeks FU
|
1.4 score on a scale
Interval 0.4 to 2.3
|
3.3 score on a scale
Interval 2.2 to 4.4
|
|
Lissamine Green Staining Scores and the Changes From Baseline
12 weeks FU
|
1.9 score on a scale
Interval 0.7 to 3.0
|
1.5 score on a scale
Interval 0.4 to 2.6
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 1 change from baseline
|
-0.7 score on a scale
Interval -1.5 to 0.0
|
-1.7 score on a scale
Interval -2.7 to -0.6
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 2 change from baseline
|
-4.9 score on a scale
Interval -6.2 to -3.6
|
—
|
|
Lissamine Green Staining Scores and the Changes From Baseline
Treatment 3 change from baseline
|
-5.4 score on a scale
Interval -6.7 to -4.0
|
—
|
|
Lissamine Green Staining Scores and the Changes From Baseline
FU 4 weeks change from baseline
|
-5.0 score on a scale
Interval -6.4 to -3.6
|
-1.4 score on a scale
Interval -3.0 to 0.2
|
|
Lissamine Green Staining Scores and the Changes From Baseline
FU 12 weeks change from baseline
|
-4.1 score on a scale
Interval -5.8 to -2.3
|
-3.2 score on a scale
Interval -4.7 to -1.7
|
Adverse Events
Tixel Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LipiFlow
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tixel Group
n=11 participants at risk
Tixel C Group: Screening and baseline visits, Treatment- 3 treatment sessions, followed by 2 Follow up sessions, 1and 3 months after last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
Tixel C: Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
|
LipiFlow
n=10 participants at risk
LipiFlow: Screening and baseline visits, Treatment- 1 single treatment session, followed by 2 Follow up sessions, 1and 3 months after the last treatment visit. Subject will be questioned about Discomfort and Pain Questionnaires (self-assessed) and OSDI questionnaire.
LipiFlow: LipiFlow
|
|---|---|---|
|
Eye disorders
Conjunctival deposit
|
9.1%
1/11 • Number of events 2 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Eye disorders
Corneal opacity
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Infections and infestations
COVID-19
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
20.0%
2/10 • Number of events 2 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Infections and infestations
Pulpitis dental
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Injury, poisoning and procedural complications
Conjunctival scar
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/11 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
10.0%
1/10 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Nervous system disorders
Migraine
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
|
Eye disorders
Chalazion
|
9.1%
1/11 • Number of events 1 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
0.00%
0/10 • 15 months and 13 days
A total of 12 device not related AEs were observed in 7 subjects (4 Tixel subjects (3.6%) and 3 (3%) LipiFlow subjects). One moderate AE ('Conjunctival deposit') was reported in one subject and resolved after medication administration and removal of conjunctival concretions. All other AEs were mild and resolved.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place