Dry Eye, Meibomian Gland Dysfunction
Conditions
Keywords
dry eye, meibomian gland dysfunction, lipiflow
Brief summary
The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.
Interventions
DEVICELipiFlow
Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
DEVICELight Based (Sham) Treatment
A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment.
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
14 subjects total were enrolled which is less than what was expected (15) due to time constraints
Participants by arm
| Arm | Count |
|---|---|
| Subject Treatment All subjects will receive light based treatment, then all subjects will receive LipiFlow treatment. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Subject Treatment |
|---|---|
| Age, Continuous | 59.57 years STANDARD_DEVIATION 16.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Dry Eye Questionnaire 5 (DEQ-5) Score
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Treatment Light Based (Sham) | Dry Eye Questionnaire 5 (DEQ-5) Score | 11.8 score on a scale | Standard Deviation 3.9 |
| Subjects Treatment LipiFlow | Dry Eye Questionnaire 5 (DEQ-5) Score | 11.8 score on a scale | Standard Deviation 4.4 |
p-value: 0.02ANOVA
Secondary
Meibomian Gland Score
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Treatment Light Based (Sham) | Meibomian Gland Score | 53.2 score on a scale | Standard Deviation 7.9 |
| Subjects Treatment LipiFlow | Meibomian Gland Score | 52.6 score on a scale | Standard Deviation 7.9 |
p-value: 0.07ANOVA
Secondary
Tear Break-Up Time (TBUT)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Treatment Light Based (Sham) | Tear Break-Up Time (TBUT) | 7.11 seconds | Standard Deviation 9.09 |
| Subjects Treatment LipiFlow | Tear Break-Up Time (TBUT) | 5.62 seconds | Standard Deviation 6.77 |
p-value: 0.66ANOVA