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| Name | Class |
|---|---|
| The American Society of Cataract and Refractive Surgery Foundation | OTHER |
| GlaxoSmithKline | INDUSTRY |
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The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3-acid ethyl esters | Active Comparator |
| |
| Corn oil capsule | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Omega-3-acid ethyl esters | Drug | 1 gram capsule by mouth four times daily for 45 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of the Ocular Surface Disease Index Score at Day 45 | The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score) | Baseline and Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Schirmer-1 Test Value at Day 45 | Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value). | Baseline and Day 45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Liang, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Eye Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3-acid Ethyl Esters | Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days |
| FG001 | Corn Oil Capsule | Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3-acid Ethyl Esters | Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days |
| BG001 | Corn Oil Capsule | Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change From Baseline of the Ocular Surface Disease Index Score at Day 45 | The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score) | Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Day 45 | eyes | eyes |
|
Adverse event data were collected for the entire duration of the 45 day trial.
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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 | Omega-3-acid Ethyl Esters | Oral Omega-3-acid ethyl esters: 1 gram capsule by mouth four times daily for 45 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Liang | Milton S. Hershey Medical Center | 717-497-9469 | dliang12@yahoo.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Placebo corn oil capsule | Drug | 1 gram by mouth 4 times daily for 45 days |
|
| Change From Baseline of Lissamine Green Staining Score at Day 45 |
Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score) |
| Baseline and Day 45 |
| Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 | Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value). | Baseline and Day 45 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Corn Oil Capsule |
Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days |
|
|
|
| Secondary | Change From Baseline of Schirmer-1 Test Value at Day 45 | Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value). | Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality. | Posted | Median | Inter-Quartile Range | millimeters | Baseline and Day 45 | eyes | eyes |
|
|
|
|
| Secondary | Change From Baseline of Lissamine Green Staining Score at Day 45 | Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score) | Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Day 45 | eyes | eyes |
|
|
|
|
| Secondary | Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 | Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value). | Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality. | Posted | Median | Inter-Quartile Range | time in seconds | Baseline and Day 45 | eyes | eyes |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Corn Oil Capsule | Placebo corn oil capsule: 1 gram by mouth 4 times daily for 45 days | 0 | 14 | 0 | 14 | 1 | 14 |
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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