Meibomian Gland Dysfunction Treatment

Sponsor
Indiana University (Other)
Overall Status
Completed
CT.gov ID
NCT04229888
Collaborator
Indiana University School of Optometry (Other)
14
1
1
12.9
1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.

Condition or Disease Intervention/Treatment Phase
  • Device: LipiFlow
  • Device: Light Based (Sham) Treatment
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.All subjects will receive first treatment and then second treatment. The eye receiving treatment will be randomly selected. The same eye will receive both treatments.
Masking:
None (Open Label)
Masking Description:
Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
Primary Purpose:
Treatment
Official Title:
Meibomian Gland Dysfunction Treatment
Actual Study Start Date :
Feb 26, 2020
Actual Primary Completion Date :
Mar 25, 2021
Actual Study Completion Date :
Mar 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subject Treatment

All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.

Device: LipiFlow
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
Other Names:
  • Johnson & Johnson
  • Device: Light Based (Sham) Treatment
    A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.

    Outcome Measures

    Primary Outcome Measures

    1. Dry Eye Questionnaire 5 (DEQ-5) Score [2 weeks]

      DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.

    Secondary Outcome Measures

    1. Meibomian Gland Score [2 weeks]

      Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)

    2. Tear Break-Up Time (TBUT) [2 weeks]

      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 TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • evidence of meibomian gland obstruction in both eyes

    • dry eye symptoms per DEQ-5

    Exclusion Criteria:
    • active ocular infection

    • previous LipiFlow treatment

    • beginning new oral or other systemic medications within prior 3 months

    • beginning new or changing dosages of ocular medications within prior 3 months

    • previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months

    • habitual contact lens wear in prior 3 months

    • women who are pregnant or nursing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University School of Optometry Bloomington Indiana United States 47405

    Sponsors and Collaborators

    • Indiana University
    • Indiana University School of Optometry

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Tichenor, Assistant Scientist, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04229888
    Other Study ID Numbers:
    • 1908329543
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    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.:
    Yes
    Keywords provided by Anna Tichenor, Assistant Scientist, Indiana University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 14 subjects total were enrolled which is less than what was expected (15) due to time constraints
    Arm/Group Title Subject Treatment
    Arm/Group Description All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
    Period Title: Overall Study
    STARTED 14
    COMPLETED 14
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Subject Treatment
    Arm/Group Description All subjects will receive light based treatment, then all subjects will receive LipiFlow treatment.
    Overall Participants 14
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    59.57
    (16.65)
    Sex: Female, Male (Count of Participants)
    Female
    12
    85.7%
    Male
    2
    14.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    14
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    14
    100%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    14
    100%

    Outcome Measures

    1. Primary Outcome
    Title Dry Eye Questionnaire 5 (DEQ-5) Score
    Description DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Subjects Treatment Light Based (Sham) Subjects Treatment LipiFlow
    Arm/Group Description All subjects will receive light based (sham) treatment. Light Based Treatment: A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment. All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
    Measure Participants 14 14
    Mean (Standard Deviation) [score on a scale]
    11.8
    (3.9)
    11.8
    (4.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Subjects Treatment Light Based (Sham), Subjects Treatment LipiFlow
    Comments
    Type of Statistical Test Non-Inferiority
    Comments To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.
    Statistical Test of Hypothesis p-Value 0.02
    Comments
    Method ANOVA
    Comments
    2. Secondary Outcome
    Title Meibomian Gland Score
    Description Meibomian glands evaluated on the lower eyelid using meibomian gland evaluator. 5 glands in 3 regions (nasal, central, temporal) evaluated and scored from 0 to 4 for a max score of 60 in each eye. (MGS scale 0 = clear, 1 = cloudy, 2 = granular, 3 = pastelike, 4 = obstruction)
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Subjects Treatment Light Based (Sham) Subjects Treatment LipiFlow
    Arm/Group Description All subjects will receive light based (sham) treatment. Light Based Treatment: A light based treatment will be used to compare effectiveness to the LipiFlow treatment. All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
    Measure Participants 14 14
    Mean (Standard Deviation) [score on a scale]
    53.2
    (7.9)
    52.6
    (7.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Subjects Treatment Light Based (Sham), Subjects Treatment LipiFlow
    Comments
    Type of Statistical Test Non-Inferiority
    Comments To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method ANOVA
    Comments
    3. Secondary Outcome
    Title Tear Break-Up Time (TBUT)
    Description 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 TBUT. A positive change value represents a lengthening in the tear break-up time and greater comfort.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Subjects Treatment Light Based (Sham) Subjects Treatment LipiFlow
    Arm/Group Description All subjects will receive light based (sham) treatment. Light Based Treatment: A light based treatment will be used to compare effectiveness to the LipiFlow treatment. All subjects will receive LipiFlow treatment. LipiFlow: Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
    Measure Participants 14 14
    Mean (Standard Deviation) [seconds]
    7.11
    (9.09)
    5.62
    (6.77)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Subjects Treatment Light Based (Sham), Subjects Treatment LipiFlow
    Comments
    Type of Statistical Test Non-Inferiority
    Comments To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.
    Statistical Test of Hypothesis p-Value 0.66
    Comments
    Method ANOVA
    Comments

    Adverse Events

    Time Frame 2 weeks
    Adverse Event Reporting Description
    Arm/Group Title Light Based (Sham) Treatment LipiFlow Treatment
    Arm/Group Description All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment.
    All Cause Mortality
    Light Based (Sham) Treatment LipiFlow Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 0/14 (0%)
    Serious Adverse Events
    Light Based (Sham) Treatment LipiFlow Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 0/14 (0%)
    Other (Not Including Serious) Adverse Events
    Light Based (Sham) Treatment LipiFlow Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14 (0%) 0/14 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Anna Tichenor
    Organization Indiana University School of Optometry
    Phone 812-855-0520
    Email annatich@iu.edu
    Responsible Party:
    Anna Tichenor, Assistant Scientist, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04229888
    Other Study ID Numbers:
    • 1908329543
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022