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. 2019 Dec 18;2019(12):CD011016. doi: 10.1002/14651858.CD011016.pub2

Follow‐up reports from the DREAM study.

Methods Study design: randomized, parallel‐group, controlled trial
Number randomized (total and per group): 535 participants
Participants Country: United States of America
Age (mean ± SD, range): 58.3 ± 13.5 years in the omega‐3 treatment group; 57.5 ± 12.6 years in the control group
Gender: 65 men and 284 women in the omega‐3 treatment group; 36 men and 150 women in the control group
Inclusion criteria:
1. Sign and date the informed consent form approved by the IRB
2. ≥ 18 years of age
3. Demonstrate at least 2 of the 4 following signs in the same eye at 2 consecutive visits. The same signs must be present in the same eye on both visits: (screening visit: 7 to 21 days before randomization, and visit 00 [baseline visit]: day of randomization)
a. Conjunctival staining present ≥ 1 (out of possible score of 6 per eye)
b. Corneal fluorescein staining present ≥ 4 (out of a possible score of 15 per eye)
c. Tear film break‐up time (TBUT) ≤ 7 seconds
d. Schirmer test ≥ 1 to ≤ 7 mm/5 min
4. Demonstrate symptoms of dry eye disease (OSDI score greater than 22 (≥ 23 to ≤ 80) at screening visit and at least 18 (≥ 18 to ≤ 80) at randomization visit
5. Have dry eye‐related ocular symptoms for at least 6 months before the screening visit and use or desire to use artificial tears on average 2 times per day in the 2 weeks preceding the screening visit
6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye
7. Women of child‐bearing potential must agree to use a reliable method of contraception during study participation and must demonstrate a negative urine pregnancy test at the screening visit
8. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff
9. Be able to swallow large, soft gel capsules
10. Demonstrate compliance with taking soft gels as directed during the run‐in period (≥ 90% taken, by pill count)
Exclusion criteria:
1. Allergic to ingredients of active or placebo pills (fish, shellfish, olive oil)
2. Contact lens wearers who are unwilling to discontinue use for 2 weeks before the baseline visit and for the duration of the study
3. Pregnant or nursing/lactating
4. Participation in a study of an investigational drug or device within the 30 days preceding the screening visit
5. Current diagnosis of any of the following ocular conditions:
i) Infection (eg, bacterial, viral, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids) or
ii) Inflammation (eg, retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)
6. History of ocular herpetic keratitis
7. Ocular surgery (including cataract surgery) within 6 months of the screening visit
8. Previous LASIK surgery or any other corneal surgery
9. Use of glaucoma medication or history of surgery for glaucoma
10. Eyelid abnormalities that affect lid function (eg, lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis)
11. Extensive ocular surface scarring or condition that may compromise ocular surface integrity such as Stevens‐Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma, etc.
12. Dry eye due to seasonal allergic conjunctivitis, or other acute or seasonal diagnosis
13. Current use of EPA/DHA supplements in excess of 1200 mg/d
14. History of liver disease
15. Currently on anticoagulation therapy such as heparin and warfarin. Use of clopidogrel (Plavix) or aspirin does not exclude the patient
16. Patients with hemophilia, thrombocytopenia, or other bleeding tendencies
17. History of atrial fibrillation
18. Uncontrolled ocular or systemic disease
19. Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation
Interventions Intervention #1: 5 soft gelatin capsules per day (daily dose of 2000 mg EPA and 1000 mg DHA)
Intervention #2 (control): 5000 mg per day of refined olive oil
Length of follow‐up: 12 months, with an extension of another 12 months
Outcomes Primary outcome(s): OSDI
Secondary outcome(s): conjunctival staining; corneal staining; TBUT; Schirmer test; tear meniscus height
Adverse events reported? (Y/N): Y
Measurement time points (specify intervals at which outcomes were assessed): baseline, 3 months, 6 months, 12 months, and 24 months (extension study only)
Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes Recruitment status: completed
Actual completion date: not reported, but completed
Last update posted: not reported