Phase 3
Completed N=535
Dry Eye Assessment and Management Study
Source: ClinicalTrials.gov NCT02128763 ↗Enrolled (actual)
535
Serious AEs
6.7%
Results posted
Jan 2019
Primary outcomePrimary: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months — -13.9; -12.5 units on a scale — p=0.40
◆ Published Evidence
Established
80citations · ~11 / year
Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study.
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.
Linked Publications (5)
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Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study.
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Prevalence of Novel Candidate Sjogren Syndrome Autoantibodies in the Dry Eye Assessment and Management (DREAM) Study.
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Effects of Omega-3 Supplementation on Exploratory Outcomes in the Dry Eye Assessment and Management Study.
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Conjunctival HLA-DR Expression and Its Association With Symptoms and Signs in the DREAM Study.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months |
-13.9; -12.5 | 0.40 |
| SECONDARY Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) |
202; 91 | 0.09 |
| SECONDARY Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale |
-9.4; -8.9 | 0.77 |
| SECONDARY Change From Baseline in SF-36 Physical Health Subscale |
0.1; 0.1 | 0.95 |
| SECONDARY Change From Baseline in SF-36 Mental Health Subscale |
-0.9; 0.4 | 0.051 |
| SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA |
2.2; 0.0 | <0.001 sig |
| SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA |
1.6; 0.0 | <0.001 sig |
| SECONDARY Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid |
-0.1; -0.1 | 0.40 |
| SECONDARY Change in Conjunctival Staining Score |
-0.4; -0.4 | 0.77 |
| SECONDARY Change in Schirmer's Test mm |
0.4; 0.3 | 0.95 |
| SECONDARY Change in Tear Film Break up Time, in Seconds |
0.7; 0.6 | 0.25 |
| SECONDARY Change in Corneal Fluorescein Staining Score |
-0.6; -0.7 | 0.61 |
| SECONDARY Change in Visual Acuity |
-0.5; -0.2 | 0.42 |
| SECONDARY Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease |
171; 93; 80; 36; 40; 23 | 0.60 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02128763) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.