Dry Eye
Conditions
Brief summary
The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE).
Interventions
DEVICEiLux® system
Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
Sponsors
Alcon Research
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is at least 18 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Has been using the same CL type (brand, material and dimensions) for \> 3 months; 5. Wears commercially available soft CLs on average \>2 hours per day, 4-7 days per week; 6. Is willing to try to wear their habitual CLs on average ≥ 6 hours per day, 4-7 days per week and maintain this for the duration of their involvement in the study; 7. Demonstrates an acceptable lens fit of their habitual contact lenses; 8. Does not have contact lens discomfort due to contact lens fit, lens material or known solution compatibility issues, in the opinion of the investigator; 9. Has at least one month supply of their habitual contact lens products at the time of the screening visit; 10. Has a CLDEQ-8 score ≥ 12; 11. Has dry eye symptoms without CL wear (OSDI ≥ 13) and has at least one of the two following signs: 1. Non-invasive tear break-up time (NITBUT) of \< 10 seconds in at least one eye; 2. Fluorescein staining: \> 5 spots of corneal staining OR \> 9 conjunctival spots OR lid wiper staining (≥ 2mm length, ≥ 25% width) in at least one eye; 12. Has a lipid layer thickness of ≤ 100 nm in both eyes; 13. A meibomian gland secretion score (MGS) of ≤ 15 for 15 glands of the lower lid in both eyes.
Exclusion criteria
1. Is participating in any concurrent clinical or research study; 2. Has used any prescription systemic medications or topical treatments for MGD or dry eye for the past 30 days prior to the screening visit and not willing to stop using these for the study duration (excluding over-the-counter artificial tears, dietary supplements and ocular lubricants but includes warm compresses, eyelid massage, eyelid hygiene, manual meibomian gland expression, punctal plug insertion or punctal occlusion, intense pulsed light treatment of the face or eyelids); 3. Has previously received treatment with an eyelid thermal pulsation device; 4. Has a history of any of the following ocular (eye or eyelid) conditions or procedures in either eye within the past 90 days prior to the screening visit: 1. Ocular trauma 2. Chemical burns 3. Ocular Herpes simplex or Herpes zoster infection 4. Limbal stem cell deficiency 5. Recurrent ocular inflammation (e.g. uveitis, iritis, scleritis, episcleritis, keratitis) 5. Has undergone ocular surgery (e.g. intraocular, oculoplastic, corneal or refractive surgery procedure) within the past 12 months prior to the screening visit; 6. Has permanent make-up or tattoos on their eyelids; 7. Has any other known active\* ocular disease and/or infection in either eye including: cicatricial lid margin disease or severe (≥ grade 3) blepharitis; moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis; a hordeolum or stye; ocular surface abnormality that may compromise corneal integrity (e.g. Grade 3 corneal fluorescein staining, recurrent corneal erosion, corneal epithelial defect, map dot fingerprint dystrophy, previously treated chemical burn); 8. Has an eyelid abnormality that affects normal lid function (e.g. entropion, ectropion, oedema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis); 9. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 10. Has any other condition that could compromise treatment or increase the risk of a procedure-related injury; 11. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 12. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 13. Has a history of sensitivity to rapidly blinking lights or photosensitive epilepsy; 14. Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrolment; 15. Is aphakic; 16. Is a member of CORE directly involved in the study; 17. Has taken part in a clinical research study within the last 30 days. \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month | 1 month | The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibomian Gland Score at 1 Month | 1 Month | To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. |
| Meibomian Gland Score at 3 Months | 3 Months | To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. |
| Comfortable Contact Lens Wear Time at Baseline | Baseline | Participants reported how long the contact lenses on average were comfortable (comfortable wear time). |
| Comfortable Contact Lens Wear Time at 1 Month | 1 Month | Participants reported how long the contact lenses on average were comfortable (comfortable wear time). |
| Comfortable Contact Lens Wear Time at 3 Months | 3 Months | Participants reported how long the contact lenses on average were comfortable (comfortable wear time). |
| Meibomian Gland Score at Baseline | Baseline | To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction. |
| Pre-lens Tear Break-up Time at 1 Month | 1 Month | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time. |
| Pre-lens Tear Break-up Time at 3 Months | 3 Months | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time. |
| Average Contact Lens Wear Time at Baseline | Baseline | Participants reported how long they wore their contact lenses on average per day (total wear time). |
| Average Contact Lens Wear Time at 1 Month | 1 Month | Participants reported how long they wore their contact lenses on average per day (total wear time). |
| Average Contact Lens Wear Time at 3 Months | 3 Months | Participants reported how long they wore their contact lenses on average per day (total wear time). |
| Pre-lens Tear Break-up Time at Baseline | Baseline | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited at a single site between November 2019 and March 2020. The first participant was enrolled on November 15, 2019 and the last participant was enrolled on March 4, 2020.
Pre-assignment details
Of 28 enrolled participants, 8 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| iLux® Treatment The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment. | 4 |
| Delayed iLux® Treatment Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated due to COVID-19 | 1 | 3 |
Baseline characteristics
| Characteristic | iLux® Treatment | Total | Delayed iLux® Treatment |
|---|---|---|---|
| Age, Continuous | 37.0 Years STANDARD_DEVIATION 19.6 | 33.6 Years STANDARD_DEVIATION 15.9 | 30.3 Years STANDARD_DEVIATION 13.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
| Standard Patient Evaluation of Eye Dryness Questionnaire score | 14 scores on a scale STANDARD_DEVIATION 6.6 | 12.9 scores on a scale STANDARD_DEVIATION 5.1 | 11.8 scores on a scale STANDARD_DEVIATION 3.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month
The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.
Time frame: 1 month
Population: 1 participant in each arm lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month | 2.0 scores on a scale | Standard Deviation 1.7 |
| Delayed iLux® Treatment | Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month | -2.0 scores on a scale | Standard Deviation 6.2 |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Average Contact Lens Wear Time at 1 Month
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: 1 Month
Population: 1 participant in each arm lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Average Contact Lens Wear Time at 1 Month | 12.3 Hours per day | Standard Deviation 5.5 |
| Delayed iLux® Treatment | Average Contact Lens Wear Time at 1 Month | 8.0 Hours per day | Standard Deviation 0 |
p-value: 0.7Wilcoxon (Mann-Whitney)
Secondary
Average Contact Lens Wear Time at 3 Months
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: 3 Months
Population: Participants lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Average Contact Lens Wear Time at 3 Months | 12.7 Hours per day | Standard Deviation 4.2 |
| Delayed iLux® Treatment | Average Contact Lens Wear Time at 3 Months | 8 Hours per day | Standard Deviation 0 |
p-value: 0.5Wilcoxon (Mann-Whitney)
Secondary
Average Contact Lens Wear Time at Baseline
Participants reported how long they wore their contact lenses on average per day (total wear time).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Average Contact Lens Wear Time at Baseline | 10.5 Hours per day | Standard Deviation 3.7 |
| Delayed iLux® Treatment | Average Contact Lens Wear Time at Baseline | 7.3 Hours per day | Standard Deviation 2.5 |
p-value: 0.343Wilcoxon (Mann-Whitney)
Secondary
Comfortable Contact Lens Wear Time at 1 Month
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: 1 Month
Population: 1 participant in each arm lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Comfortable Contact Lens Wear Time at 1 Month | 7.0 Hours per day | Standard Deviation 4.6 |
| Delayed iLux® Treatment | Comfortable Contact Lens Wear Time at 1 Month | 4.0 Hours per day | Standard Deviation 2 |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Comfortable Contact Lens Wear Time at 3 Months
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: 3 Months
Population: Participants lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Comfortable Contact Lens Wear Time at 3 Months | 9.0 Hours per day | Standard Deviation 3.6 |
| Delayed iLux® Treatment | Comfortable Contact Lens Wear Time at 3 Months | 2 Hours per day | — |
p-value: 0.5Wilcoxon (Mann-Whitney)
Secondary
Comfortable Contact Lens Wear Time at Baseline
Participants reported how long the contact lenses on average were comfortable (comfortable wear time).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Comfortable Contact Lens Wear Time at Baseline | 4.3 Hours per day | Standard Deviation 2.6 |
| Delayed iLux® Treatment | Comfortable Contact Lens Wear Time at Baseline | 2.3 Hours per day | Standard Deviation 1 |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Meibomian Gland Score at 1 Month
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Time frame: 1 Month
Population: 1 participant in each arm was lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Meibomian Gland Score at 1 Month | 21.3 scores on a scale | Standard Deviation 11.7 |
| Delayed iLux® Treatment | Meibomian Gland Score at 1 Month | 20.3 scores on a scale | Standard Deviation 10.1 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Meibomian Gland Score at 3 Months
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Time frame: 3 Months
Population: 2 participants in the iLux® treatment group were assessed remotely due to the COVID-19 shutdown. Meibomian gland score was unable to be assessed via a remote visit. 1 participant in the iLux® treatment group and 3 participants in the delayed iLux® treatment group were lost to follow-up due to COVID-19. Meibomian gland score was not assessed in the 1 person in the delayed iLux® treatment group that completed the study as per the protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iLux® Treatment | Meibomian Gland Score at 3 Months | 15 score on a scale |
Secondary
Meibomian Gland Score at Baseline
To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Meibomian Gland Score at Baseline | 10.5 scores on a scale | Standard Deviation 4.7 |
| Delayed iLux® Treatment | Meibomian Gland Score at Baseline | 10.5 scores on a scale | Standard Deviation 4.1 |
p-value: 0.057Wilcoxon (Mann-Whitney)
Secondary
Pre-lens Tear Break-up Time at 1 Month
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Time frame: 1 Month
Population: 1 participant in each arm lost to follow-up due to COVID-19.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Pre-lens Tear Break-up Time at 1 Month | 5.8 Seconds | Standard Deviation 3.9 |
| Delayed iLux® Treatment | Pre-lens Tear Break-up Time at 1 Month | 3.3 Seconds | Standard Deviation 1.3 |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Pre-lens Tear Break-up Time at 3 Months
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Time frame: 3 Months
Population: 2 participants in the iLux® treatment group had a remote visit due to the COVID-19 closure of the site. Pre-lens tear break-up time was unable to be assessed using a remote visit. 1 participant in the iLux® treatment group and 3 participants in the delayed iLux® treatment group were lost to follow-up due to COVID-19. Pre-lens tear break-up time was not assessed in the 1 person in the delayed iLux® treatment group that completed the study as per the protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iLux® Treatment | Pre-lens Tear Break-up Time at 3 Months | 5.6 Seconds |
Secondary
Pre-lens Tear Break-up Time at Baseline
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the contact lens surface after blinking is referred to as the pre-lens tear break-up time. Three measurements are taken and averaged together. A higher number represents a longer pre-lens tear break-up time.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iLux® Treatment | Pre-lens Tear Break-up Time at Baseline | 5.1 Seconds | Standard Deviation 2.9 |
| Delayed iLux® Treatment | Pre-lens Tear Break-up Time at Baseline | 4.0 Seconds | Standard Deviation 1.1 |
p-value: 1Wilcoxon (Mann-Whitney)