Dry Eye
Conditions
Brief summary
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.
Detailed description
The study is designed to: * Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial. * Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients. * Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.
Interventions
2000 mg EPA and 1000 mg DHA per day
DRUGPlacebo
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Sponsors
National Eye Institute (NEI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes. * Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline. * Symptoms of DED for greater than or equal to 6 months. * Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks. * Ability to swallow large, soft gelcaps
Exclusion criteria
* Allergic to ingredients in supplements or placebo * Contact lens wear * Pregnant, nursing, or lactating * Current ocular infection, inflammation, or acute allergic conjunctivitis * History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies * Currently on anticoagulation therapy * Eyelid abnormalities or extensive ocular scarring * Use of EPA/DHA supplements in excess of 1200 mg per dayi * Current use, insufficient washout period, or intent to change specific treatments for dry eye disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA | 12 months | 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. |
| Change in Schirmer's Test mm | 12 months | 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. |
| Change in Tear Film Break up Time, in Seconds | 12 months | 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. |
| Change in Corneal Fluorescein Staining Score | 12 months | 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. |
| Change in Visual Acuity | 12 months | 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. |
| Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | 12 months | Subjects with change in number of treatments used for dry eye disease, n.,(%) |
| Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) | 12 months | 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. |
| Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale | 12 months | 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. |
| Change From Baseline in SF-36 Physical Health Subscale | 12 months | 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. |
| Change From Baseline in SF-36 Mental Health Subscale | 12 months | 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. |
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA | 12 months | 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. |
| Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid | 12 months | 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. |
| Change in Conjunctival Staining Score | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Meniscus Height( TMH) by Keratography | 12 months | 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. |
| Change in Redness by Keratography | 12 months | 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). |
| Change in Tear Osmolarity | 12 months | 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. |
| Change in Intraocular Pressure (IOP)- mm Hg | 12 months | 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. |
| Change in Tear Break up Time by Keratography | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 349 |
| Placebo Olive oil-5 gelcaps per day
Placebo: Olive oil gelcaps manufactured to mimic Omega-3 gelcaps | 186 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 19 | 16 |
Baseline characteristics
| Characteristic | Placebo | Total | Omega-3 Supplements |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 12.6 | 58.0 years STANDARD_DEVIATION 13.2 | 58.3 years STANDARD_DEVIATION 13.5 |
| Brief Ocular Discomfort Inventory (BODI) Score | 33.4 units on a scale STANDARD_DEVIATION 16.3 | 33.2 units on a scale STANDARD_DEVIATION 15.8 | 33.2 units on a scale STANDARD_DEVIATION 15.5 |
| Conjunctival Staining | 2.9 units on a scale STANDARD_DEVIATION 1.4 | 3.0 units on a scale STANDARD_DEVIATION 1.4 | 3.1 units on a scale STANDARD_DEVIATION 1.4 |
| Corneal Staining | 3.7 point score STANDARD_DEVIATION 2.4 | 3.9 point score STANDARD_DEVIATION 2.7 | 4.0 point score STANDARD_DEVIATION 2.9 |
| DHA level in red blood cells at baseline | 3.85 percentage of total fatty acids STANDARD_DEVIATION 1.11 | 3.9 percentage of total fatty acids STANDARD_DEVIATION 1.1 | 3.91 percentage of total fatty acids STANDARD_DEVIATION 1.17 |
| EPA level in red cells | 0.56 percentage of total fatty acids STANDARD_DEVIATION 0.35 | 0.60 percentage of total fatty acids STANDARD_DEVIATION 0.4 | 0.63 percentage of total fatty acids STANDARD_DEVIATION 0.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 68 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 161 Participants | 463 Participants | 302 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Oleic Acid (OA) level in red cells | 11.10 percentage of total fatty acids STANDARD_DEVIATION 1.38 | 11.1 percentage of total fatty acids STANDARD_DEVIATION 1.3 | 11.11 percentage of total fatty acids STANDARD_DEVIATION 1.24 |
| OSDI Score | 44.1 units on a scale STANDARD_DEVIATION 14.6 | 44.1 units on a scale STANDARD_DEVIATION 14.2 | 44.6 units on a scale STANDARD_DEVIATION 14.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 19 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 64 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 42 Participants | 27 Participants |
| Race (NIH/OMB) White | 133 Participants | 398 Participants | 265 Participants |
| Region of Enrollment United States | 186 participants | 535 participants | 349 participants |
| Schimer's Test | 10.2 mm STANDARD_DEVIATION 7 | 9.8 mm STANDARD_DEVIATION 7.2 | 9.3 mm STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 150 Participants | 434 Participants | 284 Participants |
| Sex: Female, Male Male | 36 Participants | 101 Participants | 65 Participants |
| Tear Break Up Time (TBUT) | 3.1 seconds STANDARD_DEVIATION 1.6 | 3.1 seconds STANDARD_DEVIATION 1.5 | 3.1 seconds STANDARD_DEVIATION 1.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 349 | 0 / 186 |
| other Total, other adverse events | 0 / 349 | 0 / 186 |
| serious Total, serious adverse events | 21 / 349 | 15 / 186 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months | -13.9 units on a scale | Standard Deviation 15.6 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months | -12.5 units on a scale | Standard Deviation 18.2 |
p-value: 0.4Regression, Linear
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change From Baseline in SF-36 Mental Health Subscale | -0.9 score on a scale | Standard Deviation 6.3 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change From Baseline in SF-36 Mental Health Subscale | 0.4 score on a scale | Standard Deviation 7 |
p-value: 0.051Regression, Linear
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change From Baseline in SF-36 Physical Health Subscale | 0.1 score on a scale | Standard Deviation 6.9 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change From Baseline in SF-36 Physical Health Subscale | 0.1 score on a scale | Standard Deviation 6.3 |
p-value: 0.95Regression, Linear
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale | -9.4 score on a scale | Standard Deviation 15 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale | -8.9 score on a scale | Standard Deviation 16.2 |
p-value: 0.77Regression, Linear
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.
Time frame: 12 months
Population: Among eyes that qualified for the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Conjunctival Staining Score | -0.4 units on a scale | Standard Deviation 1.1 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Conjunctival Staining Score | -0.4 units on a scale | Standard Deviation 1 |
p-value: 0.77Regression, Linear
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.
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Corneal Fluorescein Staining Score | -0.6 units on a scale | Standard Deviation 1.9 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Corneal Fluorescein Staining Score | -0.7 units on a scale | Standard Deviation 1.7 |
p-value: 0.61Regression, Linear
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.
Time frame: 12 months
Population: among eligible eyes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Schirmer's Test mm | 0.4 mm | Standard Deviation 5.3 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Schirmer's Test mm | 0.3 mm | Standard Deviation 5 |
p-value: 0.95Regression, Linear
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.
Time frame: 12 months
Population: Measure is eyes, not people.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Tear Film Break up Time, in Seconds | 0.7 seconds | Standard Deviation 2.1 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Tear Film Break up Time, in Seconds | 0.6 seconds | Standard Deviation 1.6 |
p-value: 0.25Regression, Linear
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.,(%)
Time frame: 12 months
Population: Data are missing for 5 subjects in the omega -3 group and 6 subjects in the placebo group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omega-3 Supplements | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | Fewer treatments used, with no additions | 171 Participants |
| Omega-3 Supplements | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | ≤ treatments used, with ≥1 treatment switched | 40 Participants |
| Omega-3 Supplements | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | More treatments used | 33 Participants |
| Omega-3 Supplements | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | No Change | 80 Participants |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | More treatments used | 12 Participants |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | Fewer treatments used, with no additions | 93 Participants |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | No Change | 36 Participants |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease | ≤ treatments used, with ≥1 treatment switched | 23 Participants |
p-value: 0.6Chi-squared, Corrected
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.
Time frame: 12 months
Population: Each eye measured separately. Total are numbers of eyes assessed, not subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Visual Acuity | -0.5 score on a scale | Standard Deviation 5 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Visual Acuity | -0.2 score on a scale | Standard Deviation 4.8 |
p-value: 0.42Regression, Linear
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.
Time frame: 12 months
Population: Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA | 1.6 percentage of fatty acids in blood cells | Standard Deviation 1.2 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA | 0.0 percentage of fatty acids in blood cells | Standard Deviation 0.2 |
p-value: <0.001Regression, Linear
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.
Time frame: 12 months
Population: Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA | 2.2 percentage of fatty acids in blood cells | Standard Deviation 1.2 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA | 0.0 percentage of fatty acids in blood cells | Standard Deviation 0.2 |
p-value: <0.001Regression, Linear
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.
Time frame: 12 months
Population: Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid | -0.1 percentage of oleic acid in blood cells | Standard Deviation 1 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid | -0.1 percentage of oleic acid in blood cells | Standard Deviation 1 |
p-value: 0.4Regression, Linear
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omega-3 Supplements | Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) | 202 Participants |
| Placebo (5 Gms of Refined Olive Oil/Day) | Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) | 91 Participants |
p-value: 0.09Regression, Linear
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.
Time frame: 12 months
Population: Each eye measured separately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Intraocular Pressure (IOP)- mm Hg | 0.0 mmHg | Standard Deviation 2.3 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Intraocular Pressure (IOP)- mm Hg | 0.3 mmHg | Standard Deviation 2.4 |
p-value: 0.17Regression, Linear
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).
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Redness by Keratography | -0.00 score on a scale | Standard Deviation 0.34 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Redness by Keratography | -0.01 score on a scale | Standard Deviation 0.4 |
p-value: 0.66Regression, Linear
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Tear Break up Time by Keratography | -0.5 seconds | Standard Deviation 6.7 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Tear Break up Time by Keratography | -0.5 seconds | Standard Deviation 6.1 |
p-value: 0.02Regression, Linear
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Tear Meniscus Height( TMH) by Keratography | 0.00 mm | Standard Deviation 0.16 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Tear Meniscus Height( TMH) by Keratography | -0.01 mm | Standard Deviation 0.14 |
p-value: 0.71Regression, Linear
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Supplements | Change in Tear Osmolarity | -0.7 mOsms/L | Standard Deviation 21.5 |
| Placebo (5 Gms of Refined Olive Oil/Day) | Change in Tear Osmolarity | 3.6 mOsms/L | Standard Deviation 18.3 |
p-value: 0.02Regression, Linear