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| ID | Type | Description | Link |
|---|---|---|---|
| U10EY022879 | U.S. NIH Grant/Contract | View source | |
| U10EY022881 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.
The study is designed to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 supplements | Experimental | Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps |
|
| Placebo | Placebo Comparator | Olive oil-5 gelcaps per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 supplements | Drug | 2000 mg EPA and 1000 mg DHA per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months | Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) | Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. A negative change score = improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP)- mm Hg | Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure. | 12 months |
| Change in Tear Break up Time by Keratography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Penny A Asbell, MD | University of Tennessee | Study Chair |
| Maureen G Maguire, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephen Cohen, OD PC | Scottsdale | Arizona | 85254 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30161055 | Result | Bunya VY, Ying GS, Maguire MG, Kuklinski E, Lin MC, Peskin E, Asbell PA; DREAM Study Research Group. Prevalence of Novel Candidate Sjogren Syndrome Autoantibodies in the Dry Eye Assessment and Management (DREAM) Study. Cornea. 2018 Nov;37(11):1425-1430. doi: 10.1097/ICO.0000000000001714. | |
| 31022469 | Result | Daniel E, Maguire MG, Pistilli M, Bunya VY, Massaro-Giordano GM, Smith E, Kadakia PA, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study. Ocul Surf. 2019 Jul;17(3):491-501. doi: 10.1016/j.jtos.2019.04.003. Epub 2019 Apr 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Supplements | Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day |
| FG001 | Placebo | Olive oil-5 gelcaps per day containing a total of 5 grams of refined olive oil Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps |
| 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 1, 2017 |
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| Placebo |
| Drug |
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps |
|
| 12 months |
| Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale | Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement. | 12 months |
| Change From Baseline in SF-36 Physical Health Subscale | Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement. | 12 months |
| Change From Baseline in SF-36 Mental Health Subscale | Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement. | 12 months |
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA | Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit. | 12 months |
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA | Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group. | 12 months |
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid | Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn. | 12 months |
| Change in Conjunctival Staining Score | Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement. | 12 months |
| Change in Schirmer's Test mm | The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. | 12 months |
| Change in Tear Film Break up Time, in Seconds | Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement. | 12 months |
| Change in Corneal Fluorescein Staining Score | Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement. | 12 months |
| Change in Visual Acuity | Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity. | 12 months |
| Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | Subjects with change in number of treatments used for dry eye disease, n.,(%) | 12 months |
Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. |
| 12 months |
| Change in Tear Meniscus Height( TMH) by Keratography | The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. | 12 months |
| Change in Redness by Keratography | Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness). | 12 months |
| Change in Tear Osmolarity | Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement. | 12 months |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Milton M. Hom, OD, FAAO | Azusa | California | 91702 | United States |
| University of California, Berkeley | Berkeley | California | 94720 | United States |
| Pendleton Eye Center | Oceanside | California | 92056 | United States |
| Wolstan and Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Shettle Eye Research | Largo | Florida | United States |
| Eye Care Centers Management, Inc. | Morrow | Georgia | 30260 | United States |
| University of Illinois Hospital & Health Sciences | Chicago | Illinois | 60612 | United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| KU Eye Center | Prairie Village | Kansas | 66208 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| Clinical Eye Research of Boston | Winchester | Massachusetts | 01890 | United States |
| University of Michigan Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Minnesota Eye Consultants, P.A. | Bloomington | Minnesota | 55431 | United States |
| Mulqueeny Eye Centers | Creve Coeur | Missouri | 63141 | United States |
| Tauber Eye Center | Kansas City | Missouri | 64111 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Universtity of Rochester-Flaum Eye Institute | Rochester | New York | 14642 | United States |
| Oculus Research at Garner at Eyecarecenter | Raleigh | North Carolina | 27603 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Northeast Ohio Eye Surgeons | Kent | Ohio | 44240 | United States |
| Scheie Eye Institute, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Southern College of Optometry | Memphis | Tennessee | 38104 | United States |
| The Eye Centers of Racine and Kenosha | Racine | Wisconsin | 53405 | United States |
| 31445751 | Result | Oydanich M, Maguire MG, Pistilli M, Hamrah P, Greiner JV, Lin MC, Asbell PA; Dry Eye Assessment and Management Study Research Group. Effects of Omega-3 Supplementation on Exploratory Outcomes in the Dry Eye Assessment and Management Study. Ophthalmology. 2020 Jan;127(1):136-138. doi: 10.1016/j.ophtha.2019.07.009. Epub 2019 Jul 25. |
| 31489258 | Result | Roy NS, Wei Y, Yu Y, Ying GS, Kuklinski E, Barry B, Maguire MG, Dana R, Brightwell-Arnold M, Asbell PA; for the Dry Eye Assessment and Management (DREAM) Study Group. Conjunctival HLA-DR Expression and Its Association With Symptoms and Signs in the DREAM Study. Transl Vis Sci Technol. 2019 Aug 21;8(4):31. doi: 10.1167/tvst.8.4.31. eCollection 2019 Jul. |
| 32097181 | Result | Kuklinski EJ, Hom MM, Ying GS, Lin MC, Chapkin RS, Jones R, Moser A, Kim KY, Maguire MG, Asbell PA; DREAM Study Research Group. Associations Between Systemic Omega-3 Fatty Acid Levels With Moderate-to-Severe Dry Eye Disease Signs and Symptoms at Baseline in the Dry Eye Assessment and Management Study. Eye Contact Lens. 2021 Jan 1;47(1):2-7. doi: 10.1097/ICL.0000000000000687. |
| 32821497 | Result | Berg EJ, Ying GS, Maguire MG, Sheffield PE, Szczotka-Flynn LB, Asbell PA, Shen JF; DREAM Study Research Group. Climatic and Environmental Correlates of Dry Eye Disease Severity: A Report From the Dry Eye Assessment and Management (DREAM) Study. Transl Vis Sci Technol. 2020 Apr 29;9(5):25. doi: 10.1167/tvst.9.5.25. eCollection 2020 Apr. |
| 39079754 | Derived | Zhong A, Augello P, Asbell P, Ying GS; DREAM Study Research Group. Intereye Agreement in Dry-Eye Signs in the DREAM Study: Implications for Future Dry-Eye Trials. Cornea. 2025 Feb 1;44(2):149-156. doi: 10.1097/ICO.0000000000003605. Epub 2024 Jul 30. |
| 38391283 | Derived | Lee DC, Guo M, Yu Y, Bunya VY, Asbell P, Ying GS. Two-Year Progression of Dry Eye Disease in Dry Eye Assessment and Management Study. Cornea. 2024 Oct 1;43(10):1231-1237. doi: 10.1097/ICO.0000000000003503. Epub 2024 Feb 22. |
| 38345056 | Derived | Hashemi MH, Ambrus JL Jr, Shukla AA, Zhu D, Ying GS, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Association of Systemic Markers of Inflammation with Signs and Symptoms of Dry Eye Disease and Sjogren's Syndrome in the Dry Eye Assessment and Management (DREAM(c)) Study. Curr Eye Res. 2024 Jun;49(6):574-581. doi: 10.1080/02713683.2024.2312937. Epub 2024 Feb 12. |
| 36575626 | Derived | Zhao M, Yu Y, Roy NS, Ying GS, Asbell P, Bunya VY. Sex-related differences and hormonal effects in the Dry Eye Assessment and Management (DREAM) study. Br J Ophthalmol. 2023 Dec 18;108(1):23-29. doi: 10.1136/bjo-2022-322238. |
| 34294637 | Derived | Sutphin JE, Ying GS, Bunya VY, Yu Y, Lin MC, McWilliams K, Schmucker E, Kuklinski EJ, Asbell PA, Maguire MG; Dry Eye Assessment and Management (DREAM) Study Research Group. Correlation of Measures From the OCULUS Keratograph and Clinical Assessments of Dry Eye Disease in the Dry Eye Assessment and Management Study. Cornea. 2022 Jul 1;41(7):845-851. doi: 10.1097/ICO.0000000000002804. Epub 2021 Jul 21. |
| 33290317 | Derived | Sayegh RR, Yu Y, Farrar JT, Kuklinski EJ, Shtein RM, Asbell PA, Maguire MG; Dry Eye Assessment and Management (DREAM) Study Research Group. Ocular Discomfort and Quality of Life Among Patients in the Dry Eye Assessment and Management Study. Cornea. 2021 Jul 1;40(7):869-876. doi: 10.1097/ICO.0000000000002580. |
| 31425752 | Derived | Hussain M, Shtein RM, Pistilli M, Maguire MG, Oydanich M, Asbell PA; DREAM Study Research Group. The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease. Ocul Surf. 2020 Jan;18(1):47-55. doi: 10.1016/j.jtos.2019.08.002. Epub 2019 Aug 16. |
| 31116166 | Derived | Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study. Optom Vis Sci. 2019 Jun;96(6):387-396. doi: 10.1097/OPX.0000000000001387. |
| 29883769 | Derived | Asbell PA, Maguire MG, Peskin E, Bunya VY, Kuklinski EJ; Dry Eye Assessment and Management (DREAM(c)) Study Research Group. Dry Eye Assessment and Management (DREAM(c)) Study: Study design and baseline characteristics. Contemp Clin Trials. 2018 Aug;71:70-79. doi: 10.1016/j.cct.2018.06.002. Epub 2018 Jun 6. |
| 29652551 | Derived | Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Supplements | Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day |
| BG001 | Placebo | Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps |
| BG002 | 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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| 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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| OSDI Score | Ocular Surface Disease Index (OSDI) scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Brief Ocular Discomfort Inventory (BODI) Score | Brief Ocular Discomfort Inventory (BODI) scores range from 0-100. Higher scores = more discomfort. Baseline score is the mean of the screening and eligibility confirmation visit scores. | Mean | Standard Deviation | units on a scale |
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| EPA level in red cells | Baseline measure of Eicosapentaenoic Acid (EPA) (%) in red blood cells | Mean | Standard Deviation | percentage of total fatty acids |
| ||||||||||||||
| DHA level in red blood cells at baseline | Baseline measure of Docosahexanoic Acid (DHA) (%) in red blood cells | Mean | Standard Deviation | percentage of total fatty acids |
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| Oleic Acid (OA) level in red cells | Baseline level of Oleic Acid (OA) in red blood cells (%) | Mean | Standard Deviation | percentage of total fatty acids |
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| Tear Break Up Time (TBUT) | Baseline scores = the average of the screening and baseline visits. Tear Break Up Time (TBUT) is a sign of dry eye disease. Scores range between 0-20 seconds; higher is better. | Mean | Standard Deviation | seconds |
| ||||||||||||||
| Schimer's Test | The Schirmer's test determines whether the eye produces enough tears to keep the eye moist. Schirmer's test score range between <4 to >/= to 15 mm of wetting by tears per 5 minutes. Lower scores indicate more severe dry eye. | Mean | Standard Deviation | mm |
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| Conjunctival Staining | Instilling a solution into the eye and observing the staining that occurs makes visible any injury or pathology to the ocular surface. Conjunctival staining scores range between 0-6. Lower scores are better (less abnormality). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Corneal Staining | Instilling a solution into the eye and observing the staining that occurs makes visible any injury or pathology to the ocular surface. Corneal staining scores range between 0-15. Lower scores are better (less abnormality). | Mean | Standard Deviation | point score |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months | Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) | Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. A negative change score = improvement. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale | Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Change From Baseline in SF-36 Physical Health Subscale | Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Change From Baseline in SF-36 Mental Health Subscale | Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA | Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit. | Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group. | Posted | Mean | Standard Deviation | percentage of fatty acids in blood cells | 12 months |
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| Secondary | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA | Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group. | Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group. | Posted | Mean | Standard Deviation | percentage of fatty acids in blood cells | 12 months |
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| Secondary | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid | Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn. | Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group | Posted | Mean | Standard Deviation | percentage of oleic acid in blood cells | 12 months |
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| Secondary | Change in Conjunctival Staining Score | Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement. | Among eyes that qualified for the study. | Posted | Mean | Standard Deviation | units on a scale | 12 months | eyes | eyes |
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| Secondary | Change in Schirmer's Test mm | The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. | among eligible eyes | Posted | Mean | Standard Deviation | mm | 12 months | eyes | eyes |
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| Secondary | Change in Tear Film Break up Time, in Seconds | Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement. | Measure is eyes, not people. | Posted | Mean | Standard Deviation | seconds | 12 months | eyes | eyes |
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| Secondary | Change in Corneal Fluorescein Staining Score | Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement. | Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study | Posted | Mean | Standard Deviation | units on a scale | 12 months | eyes | eyes |
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| Secondary | Change in Visual Acuity | Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity. | Each eye measured separately. Total are numbers of eyes assessed, not subjects. | Posted | Mean | Standard Deviation | score on a scale | 12 months | eyes | eyes |
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| Secondary | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | Subjects with change in number of treatments used for dry eye disease, n.,(%) | Data are missing for 5 subjects in the omega -3 group and 6 subjects in the placebo group | Posted | Count of Participants | Participants | 12 months |
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| Other Pre-specified | Change in Intraocular Pressure (IOP)- mm Hg | Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure. | Each eye measured separately | Posted | Mean | Standard Deviation | mmHg | 12 months | eyes | eyes |
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| Other Pre-specified | Change in Tear Break up Time by Keratography | Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. | Each eye is measured separately. Total are number of eyes assessed, not subjects. Tear Break up Time by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants. | Posted | Mean | Standard Deviation | seconds | 12 months | eyes | eyes |
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| Other Pre-specified | Change in Tear Meniscus Height( TMH) by Keratography | The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. | Each eye measured separately. Total are number of eyes assessed, not subjects. Tear Meniscus Height by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants. | Posted | Mean | Standard Deviation | mm | 12 months | eyes | eyes |
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| Other Pre-specified | Change in Redness by Keratography | Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness). | Each eye measured separately. Total are number of eyes assessed, not subjects. Change in redness measured by keratography was only performed at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants. | Posted | Mean | Standard Deviation | score on a scale | 12 months | eyes | eyes |
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| Other Pre-specified | Change in Tear Osmolarity | Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement. | Each eye is measured separately. Total are number of eyes assessed, not subjects.Tear Osmolarity was only performed at the 18 clinical centers that owned a Tearlab osmolarity machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants. | Posted | Mean | Standard Deviation | mOsms/L | 12 months | eyes | eyes |
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AE data were collected from the safety visit to 12 months The AE reporting period was the from the screening visit to the end of the study follow-up (12 months). At the last visit, subjects were instructed to report any subsequent event(s) occurring within 30 days that the subject or a physician, believed might reasonably be related to study treatment. Subjects who withdrew early were contacted by the Clinic Coordinator 30 days after their last visit to ascertain whether any AEs occurred.
Not provided
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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 Supplements | Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps Omega-3 supplements: 2000 mg EPA and 1000 mg DHA per day | 1 | 349 | 21 | 349 | 0 | 349 |
| EG001 | Placebo | Olive oil-5 gelcaps per day Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps | 0 | 186 | 15 | 186 | 0 | 186 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| COLONIC OBSTRUCTION | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| GALLBLADER PAIN | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
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| ABDOMINAL INFECTION | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| OSTEOMYELITIS | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| SKIN INFECTION | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| CHONDROCALCINOSIS PYROPHOSPHATE | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| CHRONIC MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| FACIAL PALSY | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| ARTHRODESIS | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| COLECTOMY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| GASTROINTESTINAL ENDOSCOPIC THERAPY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| HYSTERECTOMY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| OVARIAN CYSTECTOMY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| PARATHYROIDECTOMY | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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Not provided
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen G. Maguire, PhD | University of Pennsylvania | 215-615-1501 | maguirem@pennmedicine.upenn.edu |
| Jun 27, 2018 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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