Meibomian Gland Dysfunction
Conditions
Keywords
iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye
Brief summary
The purpose of this study was to compare changes in meibomian gland dysfunction (MGD), tear break-up time (TBT) and evaporative dry eye (EDE) symptoms after treatment with either the iLux® 2020 System or the LipiFlow® Thermal Pulsation System.
Detailed description
At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.
Interventions
DEVICEiLux 2020 System
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
DEVICELipiFlow Pulsation System
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Sponsors
Tear Film Innovations, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Meibomian gland score will be assessed by a masked rater
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older of any gender or race * Written informed consent to participate in the study * Willingness and ability to return for all study visits * Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit * Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure * Tear break-up time \<10 seconds * Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)
Exclusion criteria
* History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year * Subjects with giant papillary conjunctivitis * Subject with punctal plugs or who have had punctal cautery * Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination * Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months * Subjects who are aphakic * Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc. * Active ocular infection * Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months * Ocular surface abnormality that may compromise corneal integrity * Lid surface abnormalities that affect lid function in either eye * Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4) * Systemic disease conditions that cause dry eye * Unwillingness to abstain from systemic medications known to cause dryness for the study duration * Women who are pregnant, nursing, or not utilizing adequate birth control measures * Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening * Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study * Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study) * Individuals wearing contact lenses at any time during the prior three months or during the study period * Eyelid tattoos, including permanent eyeliner makeup * Individuals that were treated with LipiFlow in either eye in the last 24 months * Individuals using another ophthalmic investigational device or agent within 30 days of study participation * Individuals who are unable to complete the required patient questionnaires in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | Baseline, Week 4 | 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. |
| Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | Baseline, Week 4 | 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. |
| Incidence (Number) of Device- or Procedure-related Adverse Events | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Discomfort Score During Treatment | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | 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. |
| Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | Baseline (Day 0), Immediately Post-Treatment (Day 0) | 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. |
| Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | Baseline (Day 0), Immediately Post-Treatment (Day 0) | 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. |
| Change From Baseline to Post-Treatment in Ocular Surface Staining | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | Corneal 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. |
| Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | Baseline, Week 4 | 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. |
| Mean Pain Score During Treatment | Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iLux 2020 System Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | 71 |
| LipiFlow Thermal Pulsation System Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | 71 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 2 | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | iLux 2020 System | LipiFlow Thermal Pulsation System | Total |
|---|---|---|---|
| Age, Customized 18 Years and Older | 71 Participants | 71 Participants | 142 Participants |
| Age, Customized Under 18 Years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 61 Participants | 68 Participants | 129 Participants |
| Region of Enrollment United States | 71 participants | 71 participants | 142 participants |
| Sex: Female, Male Female | 52 Participants | 49 Participants | 101 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 71 |
| other Total, other adverse events | 5 / 71 | 4 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
Primary
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
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.
Time frame: Baseline, Week 4
Population: All randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux Right Eye | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 17.3 score on a scale | Standard Deviation 12.1 |
| iLux Left Eye | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 18.0 score on a scale | Standard Deviation 12.2 |
| iLux Both Eyes | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 17.7 score on a scale | Standard Deviation 12.2 |
| LipiFlow Right Eye | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 18.1 score on a scale | Standard Deviation 10.8 |
| LipiFlow Left Eye | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 16.9 score on a scale | Standard Deviation 11.5 |
| LipiFlow Both Eyes | Change From Baseline to Week 4 in Meibomian Gland Score (MGS) | 17.5 score on a scale | Standard Deviation 11.1 |
95% CI: [-3.82, 3.56]
Primary
Change From Baseline to Week 4 in Tear Break-Up Time (TBT)
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.
Time frame: Baseline, Week 4
Population: All randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux Right Eye | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.86 seconds | Standard Deviation 3.72 |
| iLux Left Eye | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.73 seconds | Standard Deviation 3.72 |
| iLux Both Eyes | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.79 seconds | Standard Deviation 3.66 |
| LipiFlow Right Eye | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.69 seconds | Standard Deviation 3.31 |
| LipiFlow Left Eye | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.61 seconds | Standard Deviation 3.22 |
| LipiFlow Both Eyes | Change From Baseline to Week 4 in Tear Break-Up Time (TBT) | 2.65 seconds | Standard Deviation 3.25 |
95% CI: [-0.97, 1.16]
Primary
Incidence (Number) of Device- or Procedure-related Adverse Events
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.
Time frame: Week 4
Population: All randomized and treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iLux Right Eye | Incidence (Number) of Device- or Procedure-related Adverse Events | 4 Adverse event |
| iLux Left Eye | Incidence (Number) of Device- or Procedure-related Adverse Events | 0 Adverse event |
p-value: 0.12Fisher Exact
Secondary
Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
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.
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Population: All randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux Right Eye | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.02 logMAR | Standard Deviation 0.08 |
| iLux Left Eye | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.05 logMAR | Standard Deviation 0.11 |
| iLux Both Eyes | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.03 logMAR | Standard Deviation 0.09 |
| LipiFlow Right Eye | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.02 logMAR | Standard Deviation 0.11 |
| LipiFlow Left Eye | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.02 logMAR | Standard Deviation 0.07 |
| LipiFlow Both Eyes | Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA) | 0.02 logMAR | Standard Deviation 0.09 |
Secondary
Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
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.
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Population: All randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux Right Eye | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | 0.04 mmHg | Standard Deviation 1.44 |
| iLux Left Eye | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | -0.07 mmHg | Standard Deviation 1.54 |
| iLux Both Eyes | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | -0.01 mmHg | Standard Deviation 1.49 |
| LipiFlow Right Eye | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | 0.07 mmHg | Standard Deviation 1.94 |
| LipiFlow Left Eye | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | -0.04 mmHg | Standard Deviation 1.79 |
| LipiFlow Both Eyes | Change From Baseline to Post-Treatment in Intraocular Pressure (IOP) | 0.01 mmHg | Standard Deviation 1.86 |
Secondary
Change From Baseline to Post-Treatment in Ocular Surface Staining
Corneal 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.
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux Right Eye | 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 |
| iLux Right Eye | 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 |
| iLux Left Eye | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Day 1 Post-Treatment | -1.0 score on a scale | Standard Deviation 2 |
| iLux Left Eye | 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 |
| iLux Both Eyes | 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 1.9 |
| iLux Both Eyes | 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 |
| LipiFlow Right Eye | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Immediately Post-Treatment | 0.5 score on a scale | Standard Deviation 1.6 |
| LipiFlow Right Eye | 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 1.5 |
| LipiFlow Left Eye | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Immediately Post-Treatment | 0.4 score on a scale | Standard Deviation 1.5 |
| LipiFlow Left Eye | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Day 1 Post-Treatment | -1.2 score on a scale | Standard Deviation 1.9 |
| LipiFlow Both Eyes | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Day 1 Post-Treatment | -1.1 score on a scale | Standard Deviation 1.7 |
| LipiFlow Both Eyes | Change From Baseline to Post-Treatment in Ocular Surface Staining | Change from Baseline to Immediately Post-Treatment | 0.4 score on a scale | Standard Deviation 1.6 |
Secondary
Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
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.
Time frame: Baseline, Week 4
Population: All randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux Right Eye | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -31.0 score on a scale | Standard Deviation 18.4 |
| iLux Left Eye | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -27.3 score on a scale | Standard Deviation 19.7 |
| iLux Both Eyes | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -30.9 score on a scale | Standard Deviation 25.9 |
| LipiFlow Right Eye | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -37.0 score on a scale | Standard Deviation 30.6 |
| LipiFlow Left Eye | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -28.0 score on a scale | Standard Deviation 22.8 |
| LipiFlow Both Eyes | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -24.9 score on a scale | Standard Deviation 20 |
| LipiFlow Ocular Questions | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -27.5 score on a scale | Standard Deviation 28.4 |
| LipiFlow Trigger Questions | Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI) | -34.4 score on a scale | Standard Deviation 34.7 |
Comparison: All questions95% CI: [-8.75, 2.59]
Secondary
Mean Discomfort Score During Treatment
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.
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Population: All randomized and treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux Right Eye | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 38.9 score on a scale | Standard Deviation 24.7 |
| iLux Right Eye | Mean Discomfort Score During Treatment | Baseline (Day 0) | 56.3 score on a scale | Standard Deviation 22.3 |
| iLux Right Eye | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 23.5 score on a scale | Standard Deviation 22.5 |
| iLux Left Eye | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 36.7 score on a scale | Standard Deviation 22.5 |
| iLux Left Eye | Mean Discomfort Score During Treatment | Baseline (Day 0) | 55.9 score on a scale | Standard Deviation 21.8 |
| iLux Left Eye | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 23.7 score on a scale | Standard Deviation 22.4 |
| iLux Both Eyes | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 37.8 score on a scale | Standard Deviation 23.6 |
| iLux Both Eyes | Mean Discomfort Score During Treatment | Baseline (Day 0) | 56.1 score on a scale | Standard Deviation 22 |
| iLux Both Eyes | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 23.6 score on a scale | Standard Deviation 22.4 |
| LipiFlow Right Eye | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 22.3 score on a scale | Standard Deviation 21.2 |
| LipiFlow Right Eye | Mean Discomfort Score During Treatment | Baseline (Day 0) | 52.1 score on a scale | Standard Deviation 23.6 |
| LipiFlow Right Eye | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 24.7 score on a scale | Standard Deviation 24.2 |
| LipiFlow Left Eye | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 23.7 score on a scale | Standard Deviation 21.6 |
| LipiFlow Left Eye | Mean Discomfort Score During Treatment | Baseline (Day 0) | 52.6 score on a scale | Standard Deviation 24 |
| LipiFlow Left Eye | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 24.4 score on a scale | Standard Deviation 23.4 |
| LipiFlow Both Eyes | Mean Discomfort Score During Treatment | Baseline (Day 0) | 52.3 score on a scale | Standard Deviation 23.6 |
| LipiFlow Both Eyes | Mean Discomfort Score During Treatment | Day 1 Post-Treatment | 24.5 score on a scale | Standard Deviation 23.7 |
| LipiFlow Both Eyes | Mean Discomfort Score During Treatment | Immediately Post-Treatment (Day 0) | 23.0 score on a scale | Standard Deviation 21.3 |
Secondary
Mean Pain Score During Treatment
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.
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Population: All randomized and treated patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux Right Eye | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 25.2 score on a scale | Standard Deviation 25.1 |
| iLux Right Eye | Mean Pain Score During Treatment | Baseline (Day 0) | 34.4 score on a scale | Standard Deviation 28.6 |
| iLux Right Eye | Mean Pain Score During Treatment | Day 1 Post-Treatment | 12.0 score on a scale | Standard Deviation 15.7 |
| iLux Left Eye | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 23.6 score on a scale | Standard Deviation 23.7 |
| iLux Left Eye | Mean Pain Score During Treatment | Baseline (Day 0) | 34.0 score on a scale | Standard Deviation 28 |
| iLux Left Eye | Mean Pain Score During Treatment | Day 1 Post-Treatment | 13.0 score on a scale | Standard Deviation 17 |
| iLux Both Eyes | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 24.4 score on a scale | Standard Deviation 24.3 |
| iLux Both Eyes | Mean Pain Score During Treatment | Baseline (Day 0) | 34.2 score on a scale | Standard Deviation 28.2 |
| iLux Both Eyes | Mean Pain Score During Treatment | Day 1 Post-Treatment | 12.5 score on a scale | Standard Deviation 16.3 |
| LipiFlow Right Eye | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 10.2 score on a scale | Standard Deviation 14.6 |
| LipiFlow Right Eye | Mean Pain Score During Treatment | Baseline (Day 0) | 30.8 score on a scale | Standard Deviation 26.4 |
| LipiFlow Right Eye | Mean Pain Score During Treatment | Day 1 Post-Treatment | 11.8 score on a scale | Standard Deviation 17.8 |
| LipiFlow Left Eye | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 10.1 score on a scale | Standard Deviation 13.8 |
| LipiFlow Left Eye | Mean Pain Score During Treatment | Baseline (Day 0) | 32.6 score on a scale | Standard Deviation 27.6 |
| LipiFlow Left Eye | Mean Pain Score During Treatment | Day 1 Post-Treatment | 11.5 score on a scale | Standard Deviation 16.9 |
| LipiFlow Both Eyes | Mean Pain Score During Treatment | Baseline (Day 0) | 31.7 score on a scale | Standard Deviation 27 |
| LipiFlow Both Eyes | Mean Pain Score During Treatment | Day 1 Post-Treatment | 11.7 score on a scale | Standard Deviation 17.3 |
| LipiFlow Both Eyes | Mean Pain Score During Treatment | Immediately Post-Treatment (Day 0) | 10.1 score on a scale | Standard Deviation 14.1 |