Evaporative Dry Eye
Conditions
Keywords
Evaporative Dry Eye (EDE), Meibomian Gland Dysfunction (MGD)
Brief summary
The purpose of this study is to assess changes in meibomian gland function and evaporative dry eye symptoms after treatment with the iLux medical device.
Detailed description
Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.
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
Sponsors
Tear Film Innovations, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older of any gender or race 2. Provision of written informed consent prior to study participation 3. Willingness and ability to return for all study visits 4. A positive history of self-reported dry eye symptoms for three months prior to the study using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and a score of \> 6. 5. Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes 6. Evidence of meibomian gland (MG) obstruction, based on a total meibomian gland secretion score of \< 12 out of a maximum score of 45, for 15 glands (5 nasal, 5 medial, 5 temporal) of the lower eyelid of each eye. Glands expressed & graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
Exclusion criteria
1. History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year 2. Ocular trauma or herpetic keratitis within the previous 3 months 3. Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc. 4. Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye) 5. Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g. retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis) 6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy 7. Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye 8. Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4) 9. Ocular trauma, chemical burns, or limbal stem cell deficiency 10. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome) 11. Women who are pregnant, nursing, or not utilizing adequate birth control measures 12. Individuals who have either changed the dosing of systemic or ophthalmic medication within the past 30 days prior to screening or who are unable or unwilling to remain on a stable dosing regimen for the duration of the study 13. Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) within 2 months, or topical medications other than non-preserved artificial tears within 2 weeks. 14. Individuals using another investigational device or agent within 30 days of study participation 15. Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Meibomian Gland Secretion (MGS) Total Score | Baseline (Day 0 pretreatment), Week 1, Month 1 | Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually. |
| Change From Baseline in Tear Break-Up Time (TBUT) | Baseline (Day 0 pretreatment), Week 1, Month 1 | The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score | Baseline (Day 0 pretreatment), Week 1, Month 1 | The Standard Patient Evaluation of Eye Dryness (SPEED) survey is a validated survey that assesses both the frequency and severity of dry eye symptoms. The patient grades the frequency of symptoms (4 items) on a scale from 0 to 3 (0=never; 3=constant) and the severity of each symptom (4 items) on a scale from 0 to 4 (0=no problems; 4=intolerable). Responses to the 8 items are summed to calculate a total score ranging from 0 to 28, where 0=best and 28=worst. A negative change value indicates a perceived improvement in ocular health. Both eyes contributed to the mean. |
| Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | Baseline (Day 0 pretreatment), Month 1 | The OSDI is a validated, 12-item questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The patient grades each item on a scale from 0 to 4, where 0 is None and 4 is All of the Time. Responses to the 12 items are summed, and a formula is used to calculate a total score from 0 to 100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value represents a perceived improvement in ocular health. Both eyes contributed to the mean. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 3 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all enrolled participants.
Participants by arm
| Arm | Count |
|---|---|
| iLux 2020 System Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | iLux 2020 System |
|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants |
| Race/Ethnicity, Customized Native American | 4 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 20 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator (MGE 1000) device while viewing the eyelid margin with a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3, for a resultant overall score of 0-45 for 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. Eyes were assessed individually.
Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1
Population: All treated with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux 2020 System | Change From Baseline in Meibomian Gland Secretion (MGS) Total Score | Change from Baseline at Week 1 | 12.3 score on a scale | Standard Deviation 7.1 |
| iLux 2020 System | Change From Baseline in Meibomian Gland Secretion (MGS) Total Score | Change from Baseline at Month 1 | 14.5 score on a scale | Standard Deviation 7.9 |
Comparison: Change from Baseline in Meibomian Gland Secretion Total Score at Week 1p-value: <0.0001t-test, 2 sided
Comparison: Change from Baseline in Meibomian Gland Secretion Total Score at Month 1p-value: <0.0001t-test, 2 sided
Primary
Change From Baseline in Tear Break-Up Time (TBUT)
The investigator instilled a drop of fluorescein into the lower eyelid and asked the patient to blink several times, then stop. The time between the last blink and the first appearance of a dark spot on the cornea (formation of a dry area) on the otherwise continuously stained tear film was recorded in seconds. 3 consecutive measurements were taken, with TBUT defined as the average of the 3 measurements. A positive change value represents A positive change value represents a more stable tear film (improvement). Eyes were assessed individually.
Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1
Population: All treated with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux 2020 System | Change From Baseline in Tear Break-Up Time (TBUT) | Change from Baseline at Week 1 | 3.6 seconds | Standard Deviation 3.1 |
| iLux 2020 System | Change From Baseline in Tear Break-Up Time (TBUT) | Change from Baseline at Month 1 | 4.6 seconds | Standard Deviation 3.1 |
Comparison: Change From Baseline in Tear Break-Up Time (TBUT) at Week 1p-value: <0.0001t-test, 2 sided
Comparison: Change From Baseline in Tear Break-Up Time (TBUT) at Month 1p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
The OSDI is a validated, 12-item questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The patient grades each item on a scale from 0 to 4, where 0 is None and 4 is All of the Time. Responses to the 12 items are summed, and a formula is used to calculate a total score from 0 to 100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value represents a perceived improvement in ocular health. Both eyes contributed to the mean.
Time frame: Baseline (Day 0 pretreatment), Month 1
Population: All treated with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux 2020 System | Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score | -28.5 score on a scale | Standard Deviation 22 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
The Standard Patient Evaluation of Eye Dryness (SPEED) survey is a validated survey that assesses both the frequency and severity of dry eye symptoms. The patient grades the frequency of symptoms (4 items) on a scale from 0 to 3 (0=never; 3=constant) and the severity of each symptom (4 items) on a scale from 0 to 4 (0=no problems; 4=intolerable). Responses to the 8 items are summed to calculate a total score ranging from 0 to 28, where 0=best and 28=worst. A negative change value indicates a perceived improvement in ocular health. Both eyes contributed to the mean.
Time frame: Baseline (Day 0 pretreatment), Week 1, Month 1
Population: All treated with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iLux 2020 System | Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score | Change from Baseline at Week 1 | -8.6 score on a scale | Standard Deviation 7 |
| iLux 2020 System | Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score | Change from Baseline at Month 1 | -9.1 score on a scale | Standard Deviation 6.6 |
Comparison: Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1p-value: <0.0001t-test, 2 sided
Comparison: Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1p-value: <0.0001t-test, 2 sided