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iLux Treatment for Meibomian Gland Dysfunction (MGD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055650
Recruitment Status : Completed
First Posted : February 16, 2017
Results First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Tear Film Innovations, Inc.

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.

Condition or disease Intervention/treatment Phase
Evaporative Dry Eye Device: iLux 2020 System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iLux Treatment for Meibomian Gland Dysfunction (MGD)
Actual Study Start Date : December 7, 2015
Actual Primary Completion Date : February 18, 2016
Actual Study Completion Date : February 18, 2016

Arm Intervention/treatment
Experimental: iLux 2020 System
Meibomian gland treatment (Day 0) according to instructions for use (IFU)/User Manual
Device: iLux 2020 System
Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055650


Locations
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United States, California
TearFilm Investigative Site
Encinitas, California, United States, 92924
TearFilm Investigative Site
San Diego, California, United States, 92122
TearFilm Investigative Site
San Diego, California, United States, 92128
Sponsors and Collaborators
Tear Film Innovations, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tear Film Innovations, Inc.
ClinicalTrials.gov Identifier: NCT03055650    
Other Study ID Numbers: 2020-01
First Posted: February 16, 2017    Key Record Dates
Results First Posted: November 12, 2020
Last Update Posted: November 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tear Film Innovations, Inc.:
Evaporative Dry Eye (EDE)
Meibomian Gland Dysfunction (MGD)
Additional relevant MeSH terms:
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Dry Eye Syndromes
Meibomian Gland Dysfunction
Lacrimal Apparatus Diseases
Eye Diseases
Eyelid Diseases