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| Name | Class |
|---|---|
| Bruder Healthcare Company | UNKNOWN |
The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twice Daily Application of Bruder compress | Experimental | Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
|
| Once Daily Application of Bruder compress | Experimental | Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal |
|
| Twice Daily Application of warm washcloth | Sham Comparator | Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bruder Moist Heat Compress | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | Baseline through 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Twice Daily Application of Bruder Compress | Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
| FG001 | Group 2: Once Daily Application of Bruder Compress |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2016 | Feb 28, 2018 |
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| Washcloth | Other |
|
Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal |
| FG002 | Group 3: Twice Daily Application of Warm Washcloth | Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
| COMPLETED |
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| NOT COMPLETED |
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While 18 subjects in Group 1 completed all visits in the study, one subject's data was not used in the analysis due to poor compliance with instructions on using the Bruder compress and inaccessibility to an appropriate heating appliance for a prolonged period of time during the study period. Thus, only 17 subjects' data were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Twice Daily Application of Bruder Compress | Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
| BG001 | Group 2: Once Daily Application of Bruder Compress | Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal |
| BG002 | Group 3: Twice Daily Application of Warm Washcloth | Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Comfortable Contact Lens Wear Time | Mean | Standard Deviation | hours per day |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day) | In Gr1, 25 subjects were randomized, 18 subjects completed, 7 discontinued early and 1 subject's data was not used due to poor compliance resulting in 17 subjects analyzed. In Gr2, 18 subjects were randomized and 17 completed. In Gr3, 17 subjects were randomized and completed. | Posted | Mean | Standard Deviation | hours per day | Baseline through 1 month |
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Baseline through 1 month
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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 | Group 1: Twice Daily Application of Bruder Compress | Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Group 2: Once Daily Application of Bruder Compress | Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Group 3: Twice Daily Application of Warm Washcloth | Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jason Nichols | University of Alabama at Birmingham | 205-975-3497 | jjn@uab.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2018 | Apr 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Male |
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| Native Hawaiian or Pacific Islander |
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| Caucasian |
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| African American |
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