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The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject Treatment | Experimental | All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipiFlow | Device | Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dry Eye Questionnaire 5 (DEQ-5) Score | DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Optometry | Bloomington | Indiana | 47405 | United States |
14 subjects total were enrolled which is less than what was expected (15) due to time constraints
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject Treatment | All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subject Treatment | All subjects will receive light based treatment, then all subjects will receive LipiFlow treatment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dry Eye Questionnaire 5 (DEQ-5) Score | DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Based (Sham) Treatment | All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Tichenor | Indiana University School of Optometry | 812-855-0520 | annatich@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2020 | Jan 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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Outcomes assessor blinded to visit schedule. Participants masked to invalidity of sham treatment.
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| Light Based (Sham) Treatment | Device | A light based (sham) treatment will be used to compare effectiveness to the LipiFlow treatment. |
|
| 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. |
| 2 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 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) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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|
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| 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. | Posted | Mean | Standard Deviation | seconds | 2 weeks |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | LipiFlow Treatment | All subjects will receive light based (sham) treatment, then all subjects will receive LipiFlow treatment. | 0 | 14 | 0 | 14 | 0 | 14 |
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