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The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LipiFlow Treatment | Experimental | Treatment with LipiFlow device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipiFlow System | Device | In-office treatment for meibomian gland dysfunction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. | Baseline and 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christy Stevens, OD | TearScience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoffman Estates | Illinois | United States | ||||
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A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | LipiFlow Treatment | Treatment with LipiFlow device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LipiFlow Treatment | Treatment with LipiFlow device |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score) | Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. | Results presented are for the Intent to Treat population. | Posted | Number | Correlation coefficient | Baseline and 4 Weeks |
|
4 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 | LipiFlow Treatment | Treatment with LipiFlow device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christy Stevens, OD | TearScience, Inc. (formerly Kolis Scientific) | 919-459-4815 | cstevens@tearscience.com |
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| ID | Term |
|---|---|
| D017043 | Chalazion |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 |
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| Boston |
| Massachusetts |
| United States |
| Winchester | Massachusetts | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 50 |
| 0 |
| 50 |
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| Lacrimal Apparatus Diseases |