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Dry Eye Assessment and Management Study (DREAM)

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ClinicalTrials.gov Identifier: NCT02128763
Recruitment Status : Active, not recruiting
First Posted : May 1, 2014
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye
Interventions Drug: Omega-3 supplements
Drug: Placebo
Enrollment 535
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega-3 Supplements Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 349 186
Completed 329 170
Not Completed 20 16
Reason Not Completed
Death             1             0
Lost to Follow-up             19             16
Arm/Group Title Omega-3 Supplements Placebo Total
Hide Arm/Group Description

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Total of all reporting groups
Overall Number of Baseline Participants 349 186 535
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 349 participants 186 participants 535 participants
58.3  (13.5) 57.5  (12.6) 58.0  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 186 participants 535 participants
Female
284
  81.4%
150
  80.6%
434
  81.1%
Male
65
  18.6%
36
  19.4%
101
  18.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 186 participants 535 participants
Hispanic or Latino
44
  12.6%
24
  12.9%
68
  12.7%
Not Hispanic or Latino
302
  86.5%
161
  86.6%
463
  86.5%
Unknown or Not Reported
3
   0.9%
1
   0.5%
4
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 349 participants 186 participants 535 participants
American Indian or Alaska Native
2
   0.6%
1
   0.5%
3
   0.6%
Asian
12
   3.4%
7
   3.8%
19
   3.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
39
  11.2%
25
  13.4%
64
  12.0%
White
265
  75.9%
133
  71.5%
398
  74.4%
More than one race
4
   1.1%
5
   2.7%
9
   1.7%
Unknown or Not Reported
27
   7.7%
15
   8.1%
42
   7.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 349 participants 186 participants 535 participants
349 186 535
OSDI Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 349 participants 186 participants 535 participants
44.6  (14.1) 44.1  (14.6) 44.1  (14.2)
[1]
Measure Description: 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.
Brief Ocular Discomfort Inventory (BODI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 349 participants 186 participants 535 participants
33.2  (15.5) 33.4  (16.3) 33.2  (15.8)
[1]
Measure Description: 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.
EPA level in red cells   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total fatty acids
Number Analyzed 349 participants 186 participants 535 participants
0.63  (0.43) 0.56  (0.35) 0.60  (0.40)
[1]
Measure Description: Baseline measure of Eicosapentaenoic Acid (EPA) (%) in red blood cells
DHA level in red blood cells at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total fatty acids
Number Analyzed 349 participants 186 participants 535 participants
3.91  (1.17) 3.85  (1.11) 3.9  (1.1)
[1]
Measure Description: Baseline measure of Docosahexanoic Acid (DHA) (%) in red blood cells
Oleic Acid (OA) level in red cells   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of total fatty acids
Number Analyzed 349 participants 186 participants 535 participants
11.11  (1.24) 11.10  (1.38) 11.1  (1.3)
[1]
Measure Description: Baseline level of Oleic Acid (OA) in red blood cells (%)
Tear Break Up Time (TBUT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 349 participants 186 participants 535 participants
3.1  (1.4) 3.1  (1.6) 3.1  (1.5)
[1]
Measure Description: 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.
Schimer's Test   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 349 participants 186 participants 535 participants
9.3  (6.2) 10.2  (7.0) 9.8  (7.2)
[1]
Measure Description: 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.
Conjunctival Staining   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 349 participants 186 participants 535 participants
3.1  (1.4) 2.9  (1.4) 3.0  (1.4)
[1]
Measure Description: 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).
Corneal Staining   [1] 
Mean (Standard Deviation)
Unit of measure:  Point score
Number Analyzed 349 participants 186 participants 535 participants
4.0  (2.9) 3.7  (2.4) 3.9  (2.7)
[1]
Measure Description: 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).
1.Primary Outcome
Title Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.9  (15.6) -12.5  (18.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments P value refers to difference between group on change in overall OSDI score (Row 1).
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day (5 gms of refined olive oil/day)

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Measure Type: Count of Participants
Unit of Measure: Participants
202
  61.4%
91
  53.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Supplements Placebo (5 Gms Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Mean (Standard Deviation)
Unit of Measure: score on a scale
-9.4  (15.0) -8.9  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Regression, Linear
Comments Pos hoc application of the Benjamini-Hochberg adjustment
4.Secondary Outcome
Title Change From Baseline in SF-36 Physical Health Subscale
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day (5 gms of refined olive oil/day)

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.1  (6.9) 0.1  (6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in SF-36 Mental Health Subscale
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.9  (6.3) 0.4  (7.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
6.Secondary Outcome
Title Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 309 155
Mean (Standard Deviation)
Unit of Measure: percentage of fatty acids in blood cells
2.2  (1.2) 0.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
7.Secondary Outcome
Title Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 309 155
Mean (Standard Deviation)
Unit of Measure: percentage of fatty acids in blood cells
1.6  (1.2) 0.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
8.Secondary Outcome
Title Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 309 155
Mean (Standard Deviation)
Unit of Measure: percentage of oleic acid in blood cells
-0.1  (1.0) -0.1  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
9.Secondary Outcome
Title Change in Conjunctival Staining Score
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among eyes that qualified for the study.
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
629 327
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (1.1) -0.4  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
10.Secondary Outcome
Title Change in Schirmer's Test mm
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
among eligible eyes
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
629 327
Mean (Standard Deviation)
Unit of Measure: mm
0.4  (5.3) 0.3  (5.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
11.Secondary Outcome
Title Change in Tear Film Break up Time, in Seconds
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Measure is eyes, not people.
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
629 327
Mean (Standard Deviation)
Unit of Measure: seconds
0.7  (2.1) 0.6  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
12.Secondary Outcome
Title Change in Corneal Fluorescein Staining Score
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
629 327
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.9) -0.7  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
13.Secondary Outcome
Title Change in Visual Acuity
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each eye measured separately. Total are numbers of eyes assessed, not subjects.
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
656 340
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.5  (5.0) -0.2  (4.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
14.Secondary Outcome
Title Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
Hide Description Subjects with change in number of treatments used for dry eye disease, n.,(%)
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for 5 subjects in the omega -3 group and 6 subjects in the placebo group
Arm/Group Title Omega-3 Supplements Placebo (5 Gms of Refined Olive Oil/Day)
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 324 164
Measure Type: Count of Participants
Unit of Measure: Participants
Fewer treatments used, with no additions
171
  52.8%
93
  56.7%
No Change
80
  24.7%
36
  22.0%
≤ treatments used, with ≥1 treatment switched
40
  12.3%
23
  14.0%
More treatments used
33
  10.2%
12
   7.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo (5 Gms of Refined Olive Oil/Day)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
15.Other Pre-specified Outcome
Title Change in Intraocular Pressure (IOP)- mm Hg
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each eye measured separately
Arm/Group Title Omega-3 Supplements Placebo
Hide Arm/Group Description:

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Overall Number of Participants Analyzed 329 170
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
658 340
Mean (Standard Deviation)
Unit of Measure: mmHg
0.0  (2.3) 0.3  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omega-3 Supplements, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
16.Other Pre-specified Outcome
Title Change in Contrast Sensitivity
Hide Description Contrast sensitivity measures the ability to distinguish between finer and finer increments of light versus dark. Higher score is better functioning. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.
Time Frame 12 months
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Change in Tear Break up Time by Keratography
Hide Description 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.
Time Frame 12 months
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Change in Tear Meniscus Height( TMH) by Keratography
Hide Description 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.
Time Frame 12 months
Outcome Measure Data Not Reported
19.Other Pre-specified Outcome
Title Change in Redness by Keratography
Hide Description 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.
Time Frame 12 months
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title Change in Tear Osmolarity
Hide Description 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.
Time Frame 12 months
Outcome Measure Data Not Reported
21.Other Pre-specified Outcome
Title Change in Tear Cytokine Level
Hide Description Change in levels of tear cytokines (inflammation). Change is the average of values from 6 and 12 months minus average of the eligibility confirmation visits.
Time Frame 12 months
Outcome Measure Data Not Reported
22.Other Pre-specified Outcome
Title Change in Ocular Surface Cell HLA-DR Expression
Hide Description Change is the average of values from 6 and 12 months minus average of the eligibility confirmation visits.
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3 Supplements Placebo
Hide Arm/Group Description

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

Olive oil-5 gelcaps per day

Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

All-Cause Mortality
Omega-3 Supplements Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/349 (0.29%)      0/186 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Supplements Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/349 (6.02%)      15/186 (8.06%)    
Cardiac disorders     
ATRIAL FIBRILLATION  1  1/349 (0.29%)  1 1/186 (0.54%)  1
ATRIAL FLUTTER  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Gastrointestinal disorders     
COLITIS  1  1/349 (0.29%)  1 0/186 (0.00%)  0
COLONIC OBSTRUCTION  1  1/349 (0.29%)  1 0/186 (0.00%)  0
DYSPEPSIA  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Hepatobiliary disorders     
GALLBLADER PAIN  1  0/349 (0.00%)  0 1/186 (0.54%)  1
Immune system disorders     
HYPERSENSITIVITY  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Infections and infestations     
ABDOMINAL INFECTION  1  1/349 (0.29%)  1 0/186 (0.00%)  0
OSTEOMYELITIS  1  0/349 (0.00%)  0 1/186 (0.54%)  1
SKIN INFECTION  1  0/349 (0.00%)  0 1/186 (0.54%)  1
Injury, poisoning and procedural complications     
FALL  1  1/349 (0.29%)  1 0/186 (0.00%)  0
HIP FRACTURE  1  1/349 (0.29%)  1 0/186 (0.00%)  0
SUBDURAL HAEMATOMA  1  0/349 (0.00%)  0 1/186 (0.54%)  1
Musculoskeletal and connective tissue disorders     
CHONDROCALCINOSIS PYROPHOSPHATE  1  0/349 (0.00%)  0 1/186 (0.54%)  1
NECK PAIN  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BREAST CANCER  1  0/349 (0.00%)  0 1/186 (0.54%)  1
CHRONIC MYELOID LEUKAEMIA  1  1/349 (0.29%)  1 0/186 (0.00%)  0
LYMPHOMA  1  1/349 (0.29%)  1 1/186 (0.54%)  1
MALIGNANT MELANOMA  1  1/349 (0.29%)  1 0/186 (0.00%)  0
SQUAMOUS CELL CARCINOMA  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Nervous system disorders     
FACIAL PALSY  1  0/349 (0.00%)  0 1/186 (0.54%)  1
Psychiatric disorders     
PSYCHOTIC DISORDER  1  1/349 (0.29%)  2 0/186 (0.00%)  0
Renal and urinary disorders     
HYDRONEPHROSIS  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
PNEUMONIA ASPIRATION  1  1/349 (0.29%)  1 0/186 (0.00%)  0
PNEUMOTHORAX  1  1/349 (0.29%)  1 0/186 (0.00%)  0
PULMONARY EMBOLISM  1  1/349 (0.29%)  1 0/186 (0.00%)  0
Surgical and medical procedures     
ARTHRODESIS  1  0/349 (0.00%)  0 1/186 (0.54%)  1
CHOLECYSTECTOMY  1  0/349 (0.00%)  0 2/186 (1.08%)  2
COLECTOMY  1  1/349 (0.29%)  1 0/186 (0.00%)  0
GASTROINTESTINAL ENDOSCOPIC THERAPY  1  1/349 (0.29%)  1 0/186 (0.00%)  0
HYSTERECTOMY  1  1/349 (0.29%)  1 0/186 (0.00%)  0
KNEE ARTHROPLASTY  1  1/349 (0.29%)  1 1/186 (0.54%)  1
OVARIAN CYSTECTOMY  1  1/349 (0.29%)  1 0/186 (0.00%)  0
PARATHYROIDECTOMY  1  0/349 (0.00%)  0 1/186 (0.54%)  1
Vascular disorders     
DEEP VEIN THROMBOSIS  1  0/349 (0.00%)  0 1/186 (0.54%)  1
HYPERTENSION  1  1/349 (0.29%)  1 0/186 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omega-3 Supplements Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/349 (0.00%)      0/186 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Maureen G. Maguire, PhD
Organization: University of Pennsylvania
Phone: 215-615-1501
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02128763     History of Changes
Other Study ID Numbers: UPenn IRB Protocol 816490
U10EY022879 ( U.S. NIH Grant/Contract )
U10EY022881 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2014
First Posted: May 1, 2014
Results First Submitted: August 28, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019