DRy Eye Evaluation And Management (DREAM)
The DRy Eye Evaluation And Management (DREAM) Study is a multi-center, double masked randomized clinical trial that is funded by the National Eye Institute to evaluate the efficacy and safety of omega 3 fatty acids (fish oil) compared to placebo in patients with mild to moderate dry eye disease (DED).
What is Dry Eye Disease and why is DREAM important?
Dry eye disease occurs when the eye does not produce tears properly, or when the tears produced are not of the correct consistency and evaporate too quickly. Tears are necessary for overall eye health and clear vision. Tears keep the surface of the eye moist and wash away debris. They also help protect the eye from bacterial and other types of infections.
Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry environments. Inflammation of the surface of the eye may occur with dry eye. If left untreated, this condition can lead to chronic pain, scars on the cornea, and vision impairment.
Nearly five million Americans 50 years of age and older are estimated to have dry eye disease and tens of millions more have less severe symptoms. Although highly prevalent, there are few options for patients beyond frequent administration of artificial tears.
Omega 3 fatty acids have been shown to ameliorate inflammatory reactions, including those seen in DED. There is increasing interest in using omega 3 fatty acids to treat DED, but no randomized clinical studies have tested the efficacy and safety supplementation. The DREAM Study will test the hypothesis that oral use of omega 3 fatty acids reduces the symptoms of DED and will assess potential biomarkers for DED.
To enhance the generalizability of DREAM results, the study was designed to include dry eye patients with a wide variety of symptoms associated with moderate to severe DED. To ensure that participants had chronic DED, potential study participants were assessed at both a screening visit and a baseline visit prior to randomization. Participants returned for in-clinic study visits at 3, 6 and 12 months. Compliance was assessed via analysis of the levels of omega 3 fatty acids in the blood and by pill counts. The primary outcome is change in dry eye symptoms, as assessed by the participant on the Ocular Surface Disease Inventory (OSDI), a widely used, validated DE symptom score. For more information on the DREAM Study design, please click here.
Status of the DREAM Study
535 participants enrolled at 27 Clinical Centers throughout the US were randomized to receive either a daily dose of 3 grams of omega 3 fatty acids or placebo (olive oil) and were followed for at least one year. Follow-up ended in August 2017. The main study results were published in the New England Journal of Medicine (see below). Work on additional manuscripts is underway.
DREAM Study Results
In April 2018, the DREAM study results were published in the New England Journal of Medicine. After one year, DREAM participants in both treatment groups demonstrated improvement in the signs and symptoms of dry eye disease. However, no evidence was found of a beneficial effect of omega 3 supplements on the symptoms and signs of dry eye disease relative to placebo supplement. For more details on the one-year results, click here
CPOB's Role in DREAM
In serving as the Coordinating Center for the DREAM Study, CPOB provides expertise on study design, statistical analysis, database development and management and contributes to the success of the trial in fully evaluating the effects of the treatment regimens through leadership, organization and communication. It is the Coordinating Center’s responsibility to ensure that the protocol is strictly executed by all participating units and serves a resource to the clinical centers, laboratories, and to the Office of the Study Chair.
The Scheie Image Reading Center also contributes to the DREAM Study by providing expert grading of images of the meibomian gland, which are glands at the rim of the eyelids. Meibomian glands are responsible for the supply of meibum, an oily substance that prevents the evaporation of the eye’s tear film. Meibomian gland dysfunction is a major factor in Dry Eye Disease. For more information about the DREAM Study, visit clinicaltrials.gov and also click here.