Trial Outcomes & Findings for Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction (NCT NCT03055832)
NCT ID: NCT03055832
Last Updated: 2023-04-12
Results Overview
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.
COMPLETED
NA
142 participants
Baseline, Week 4
2023-04-12
Participant Flow
Participant milestones
| Measure |
iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
LipiFlow Thermal Pulsation System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
|---|---|---|
|
Baseline
STARTED
|
71
|
71
|
|
Baseline
COMPLETED
|
71
|
71
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Immediately Post-Procedure (Hour 1)
STARTED
|
71
|
71
|
|
Immediately Post-Procedure (Hour 1)
COMPLETED
|
71
|
71
|
|
Immediately Post-Procedure (Hour 1)
NOT COMPLETED
|
0
|
0
|
|
Day 1
STARTED
|
71
|
71
|
|
Day 1
COMPLETED
|
71
|
71
|
|
Day 1
NOT COMPLETED
|
0
|
0
|
|
Week 2
STARTED
|
71
|
71
|
|
Week 2
COMPLETED
|
70
|
71
|
|
Week 2
NOT COMPLETED
|
1
|
0
|
|
Week 4
STARTED
|
70
|
71
|
|
Week 4
COMPLETED
|
70
|
71
|
|
Week 4
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
LipiFlow Thermal Pulsation System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
|---|---|---|
|
Week 2
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
iLux 2020 System
n=71 Participants
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
LipiFlow Thermal Pulsation System
n=71 Participants
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Under 18 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18 Years and Older
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=5 Participants
|
71 participants
n=7 Participants
|
142 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: All randomized and treated patients
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.
Outcome measures
| Measure |
iLux Right Eye
n=70 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=70 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=140 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=70 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=71 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=141 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
|
17.3 score on a scale
Standard Deviation 12.1
|
18.0 score on a scale
Standard Deviation 12.2
|
17.7 score on a scale
Standard Deviation 12.2
|
18.1 score on a scale
Standard Deviation 10.8
|
16.9 score on a scale
Standard Deviation 11.5
|
17.5 score on a scale
Standard Deviation 11.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 4Population: All randomized and treated patients
Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
Outcome measures
| Measure |
iLux Right Eye
n=70 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=70 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=140 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=71 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=71 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
|
2.86 seconds
Standard Deviation 3.72
|
2.73 seconds
Standard Deviation 3.72
|
2.79 seconds
Standard Deviation 3.66
|
2.69 seconds
Standard Deviation 3.31
|
2.61 seconds
Standard Deviation 3.22
|
2.65 seconds
Standard Deviation 3.25
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4Population: All randomized and treated patients
The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.
Outcome measures
| Measure |
iLux Right Eye
n=70 Participants
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Participants
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Incidence (Number) of Device- or Procedure-related Adverse Events
|
4 Adverse event
|
0 Adverse event
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: All randomized and treated patients
The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. Each item is scored on a 0-4 Likert-type scale, where 0 is "None" and 4 is "All of the Time." The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement.
Outcome measures
| Measure |
iLux Right Eye
n=70 Participants
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=70 Participants
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=70 Participants
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=70 Participants
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=71 Participants
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=71 Participants
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
n=70 Participants
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
n=71 Participants
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
|
-31.0 score on a scale
Standard Deviation 18.4
|
-27.3 score on a scale
Standard Deviation 19.7
|
-30.9 score on a scale
Standard Deviation 25.9
|
-37.0 score on a scale
Standard Deviation 30.6
|
-28.0 score on a scale
Standard Deviation 22.8
|
-24.9 score on a scale
Standard Deviation 20.0
|
-27.5 score on a scale
Standard Deviation 28.4
|
-34.4 score on a scale
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-TreatmentPopulation: All randomized and treated patients
The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of "hurts a little". Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
iLux Right Eye
n=71 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=69 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=70 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=139 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Mean Pain Score During Treatment
Baseline (Day 0)
|
34.4 score on a scale
Standard Deviation 28.6
|
34.0 score on a scale
Standard Deviation 28.0
|
34.2 score on a scale
Standard Deviation 28.2
|
30.8 score on a scale
Standard Deviation 26.4
|
32.6 score on a scale
Standard Deviation 27.6
|
31.7 score on a scale
Standard Deviation 27.0
|
—
|
—
|
|
Mean Pain Score During Treatment
Immediately Post-Treatment (Day 0)
|
25.2 score on a scale
Standard Deviation 25.1
|
23.6 score on a scale
Standard Deviation 23.7
|
24.4 score on a scale
Standard Deviation 24.3
|
10.2 score on a scale
Standard Deviation 14.6
|
10.1 score on a scale
Standard Deviation 13.8
|
10.1 score on a scale
Standard Deviation 14.1
|
—
|
—
|
|
Mean Pain Score During Treatment
Day 1 Post-Treatment
|
12.0 score on a scale
Standard Deviation 15.7
|
13.0 score on a scale
Standard Deviation 17.0
|
12.5 score on a scale
Standard Deviation 16.3
|
11.8 score on a scale
Standard Deviation 17.8
|
11.5 score on a scale
Standard Deviation 16.9
|
11.7 score on a scale
Standard Deviation 17.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-TreatmentPopulation: All randomized and treated patients
The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
iLux Right Eye
n=71 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=69 Participants
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=70 Participants
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=70 Participants
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Mean Discomfort Score During Treatment
Baseline (Day 0)
|
56.3 score on a scale
Standard Deviation 22.3
|
55.9 score on a scale
Standard Deviation 21.8
|
56.1 score on a scale
Standard Deviation 22.0
|
52.1 score on a scale
Standard Deviation 23.6
|
52.6 score on a scale
Standard Deviation 24.0
|
52.3 score on a scale
Standard Deviation 23.6
|
—
|
—
|
|
Mean Discomfort Score During Treatment
Immediately Post-Treatment (Day 0)
|
38.9 score on a scale
Standard Deviation 24.7
|
36.7 score on a scale
Standard Deviation 22.5
|
37.8 score on a scale
Standard Deviation 23.6
|
22.3 score on a scale
Standard Deviation 21.2
|
23.7 score on a scale
Standard Deviation 21.6
|
23.0 score on a scale
Standard Deviation 21.3
|
—
|
—
|
|
Mean Discomfort Score During Treatment
Day 1 Post-Treatment
|
23.5 score on a scale
Standard Deviation 22.5
|
23.7 score on a scale
Standard Deviation 22.4
|
23.6 score on a scale
Standard Deviation 22.4
|
24.7 score on a scale
Standard Deviation 24.2
|
24.4 score on a scale
Standard Deviation 23.4
|
24.5 score on a scale
Standard Deviation 23.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-TreatmentCorneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, \& central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
iLux Right Eye
n=71 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=70 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=70 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=140 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Post-Treatment in Ocular Surface Staining
Change from Baseline to Immediately Post-Treatment
|
0.6 score on a scale
Standard Deviation 1.7
|
0.6 score on a scale
Standard Deviation 1.7
|
0.6 score on a scale
Standard Deviation 1.7
|
0.5 score on a scale
Standard Deviation 1.6
|
0.4 score on a scale
Standard Deviation 1.5
|
0.4 score on a scale
Standard Deviation 1.6
|
—
|
—
|
|
Change From Baseline to Post-Treatment in Ocular Surface Staining
Change from Baseline to Day 1 Post-Treatment
|
-0.9 score on a scale
Standard Deviation 1.8
|
-1.0 score on a scale
Standard Deviation 2.0
|
-0.9 score on a scale
Standard Deviation 1.9
|
-0.9 score on a scale
Standard Deviation 1.5
|
-1.2 score on a scale
Standard Deviation 1.9
|
-1.1 score on a scale
Standard Deviation 1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Immediately Post-Treatment (Day 0)Population: All randomized and treated patients
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
iLux Right Eye
n=71 Participants
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=69 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=69 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=138 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
|
0.04 mmHg
Standard Deviation 1.44
|
-0.07 mmHg
Standard Deviation 1.54
|
-0.01 mmHg
Standard Deviation 1.49
|
0.07 mmHg
Standard Deviation 1.94
|
-0.04 mmHg
Standard Deviation 1.79
|
0.01 mmHg
Standard Deviation 1.86
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Immediately Post-Treatment (Day 0)Population: All randomized and treated patients
Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
iLux Right Eye
n=71 Eyes
Right Eye of Subjects treated with the iLux 2020 System
|
iLux Left Eye
n=71 Eyes
Left Eye of Subjects treated with the iLux 2020 System
|
iLux Both Eyes
n=142 Eyes
Both Eyes of Subjects treated with the iLux 2020 System
|
LipiFlow Right Eye
n=70 Eyes
Right Eye of Subjects Treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Left Eye
n=70 Eyes
Left Eye of Subjects treated with Lipiflow Thermal Pulsation System
|
LipiFlow Both Eyes
n=140 Eyes
Both Eyes of Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Ocular Questions
OSDI questions 6-9 in Subjects treated with the LipiFlow Thermal Pulsation System
|
LipiFlow Trigger Questions
OSDI questions 10-12 in Subjects treated with the LipiFlow Thermal Pulsation System
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
|
0.02 logMAR
Standard Deviation 0.08
|
0.05 logMAR
Standard Deviation 0.11
|
0.03 logMAR
Standard Deviation 0.09
|
0.02 logMAR
Standard Deviation 0.11
|
0.02 logMAR
Standard Deviation 0.07
|
0.02 logMAR
Standard Deviation 0.09
|
—
|
—
|
Adverse Events
iLux 2020 System
LipiFlow Thermal Pulsation System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
iLux 2020 System
n=71 participants at risk
Meibomian Gland Treatment
iLux 2020 System: Heating and compression to express clogged meibomian glands
|
LipiFlow Thermal Pulsation System
n=71 participants at risk
Meibomian Gland Treatment
LipiFlow Pulsation System: Heating and compression to express clogged meibomian glands
|
|---|---|---|
|
Eye disorders
Other
|
7.0%
5/71 • Number of events 5 • 4 weeks
Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, \& 4 weeks post-procedure.
|
5.6%
4/71 • Number of events 4 • 4 weeks
Any untoward and unintended sign, symptom or disease temporally associated with the use of an investigational drug or device, or other protocol-imposed intervention, regardless of the suspected cause. Chronic but stable conditions or diseases are not AEs. Changes in a chronic condition or disease consistent with natural disease progression are not AEs. AEs were assessed during procedure, immediately post-procedure, 1 day, 2 weeks, \& 4 weeks post-procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place