Meibomian Gland DysfunctionNCT03055832
Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
A study testing iLux 2020 System and LipiFlow Pulsation System in people with Meibomian Gland Dysfunction, run by Tear Film Innovations, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- iLux 2020 System and LipiFlow Pulsation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Feb 2017to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
TearFilm Investigative Site
Centennial, Colorado, 80112
TearFilm Investigative Site
Chesterfield, Missouri, 63017
TearFilm Investigative Site
Greenwood Village, Colorado, 80111
TearFilm Investigative Site
Kansas City, Missouri, 64111
TearFilm Investigative Site
Phoenix, Arizona, 85016
TearFilm Investigative Site
San Diego, California, 92122
TearFilm Investigative Site
Scottsdale, Arizona, 95260
About this study
Official title: Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
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.
Read the detailed description
At the Baseline visit (Day 0), subjects were assessed pre-treatment, during treatment, and post-treatment.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- iLux 2020 System, LipiFlow Pulsation System
- Keywords
- iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLux 2020 SystemDevice
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
LipiFlow Pulsation SystemDevice
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
| Study group | Role | What they receive |
|---|---|---|
| iLux 2020 System | Experimental | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Receives: Device: iLux 2020 System |
| LipiFlow Thermal Pulsation System | Active comparator | Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual Receives: Device: LipiFlow Pulsation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 4
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.
Measured: Week 4
Secondary outcomes (6)
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.
Measured: Baseline, Week 4
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.
Measured: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
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.
Measured: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
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.
Measured: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
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.
Measured: Baseline (Day 0), Immediately Post-Treatment (Day 0)
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.
Measured: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start9 Feb 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tear Film Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055832
- Sponsor's protocol ID
- 2020-03
- Status last verified
- May 2019
- First submitted
- 10 Feb 2017
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between iLux™ and LipiFlow® in the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT03055832
- Acronym / sponsor ID
- 2020-03
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- iLux, LipiFlow, dry eye, Meibomian Gland Dysfunction, evaporative dry eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Tear Film Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLux 2020 System | Experimental | Device: iLux 2020 SystemMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
| LipiFlow Thermal Pulsation System | Active comparator | Device: LipiFlow Pulsation SystemMeibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iLux 2020 SystemMedical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands | Device | iLux 2020 System |
| LipiFlow Pulsation SystemMedical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content | Device | LipiFlow Thermal Pulsation System |
Primary outcome
Change From Baseline to Week 4 in Meibomian Gland Score (MGS)
Time frame: 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)
Time frame: 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
Time frame: 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.
6 secondary outcomes
Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)
Time frame: Baseline, Week 4
Mean Pain Score During Treatment
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Mean Discomfort Score During Treatment
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Change From Baseline to Post-Treatment in Ocular Surface Staining
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment
Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)
Time frame: Baseline (Day 0), Immediately Post-Treatment (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLux 2020 System and LipiFlow Pulsation System in people with Meibomian Gland Dysfunction, run by Tear Film Innovations, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 4 in Meibomian Gland Score (MGS) (time frame: Baseline, Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.