Meibomian Gland Dysfunction Treatment
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 |
---|---|---|
|
N/A |
Study Design
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:
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
- 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
- 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)
- 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
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.- 1908329543
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
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 |
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 |
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
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 |
annatich@iu.edu |
- 1908329543