- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055650
iLux Treatment for Meibomian Gland Dysfunction (MGD)
October 20, 2020 updated by: Tear Film Innovations, Inc.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Encinitas, California, United States, 92924
- TearFilm Investigative Site
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San Diego, California, United States, 92122
- TearFilm Investigative Site
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San Diego, California, United States, 92128
- TearFilm Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 years and older of any gender or race
- Provision of written informed consent prior to study participation
- Willingness and ability to return for all study visits
- 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.
- Need for regular use of artificial tears, lubricants, or rewetting drops in both eyes
- 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:
- History of ocular surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
- Ocular trauma or herpetic keratitis within the previous 3 months
- Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
- 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)
- 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)
- 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
- Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye
- Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
- Ocular trauma, chemical burns, or limbal stem cell deficiency
- 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)
- Women who are pregnant, nursing, or not utilizing adequate birth control measures
- 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
- 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.
- Individuals using another investigational device or agent within 30 days of study participation
- Contact lens wearers or individuals who have worn contact lenses in the last 30 days or anticipate wearing contact lenses during this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
|
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Meibomian Gland Secretion (MGS) Total Score
Time Frame: 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.
|
Baseline (Day 0 pretreatment), Week 1, Month 1
|
Change From Baseline in Tear Break-Up Time (TBUT)
Time Frame: 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.
|
Baseline (Day 0 pretreatment), Week 1, Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score
Time Frame: 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.
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Baseline (Day 0 pretreatment), Week 1, Month 1
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
Time Frame: 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.
|
Baseline (Day 0 pretreatment), Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 7, 2015
Primary Completion (ACTUAL)
February 18, 2016
Study Completion (ACTUAL)
February 18, 2016
Study Registration Dates
First Submitted
February 10, 2017
First Submitted That Met QC Criteria
February 13, 2017
First Posted (ACTUAL)
February 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 12, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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