Ophthalmologists at Scheie are researching the impact of omega-3 supplements on DED. Scheie is one of 25 eye centers across the country involved in the Dry Eye Assessment and Management (DREAM) study, which seeks to test the efficacy and safety of omega-3 fatty acids as a treatment for DED.
DREAM’s germination occurred a number of years ago, when Dr. Penny Asbell of the Icahn School of Medicine at Mount Sinai approached Dr. Maureen Maguire, Director of the Center for Preventative Ophthalmology and Biostatistics (CPOB) at the University of Pennsylvania, with an idea for a multi-center clinical trial. At the time, there were very few treatments for DED that worked, and Dr. Asbell was interested in whether omega-3 fatty acid supplementation actually helped dry eye.
Dr. Maguire agreed to collaborate with Dr. Asbell on the study planning process. They received an $8 million grant from the National Eye Institute (NEI), making DREAM the first NEI-funded randomized controlled trial on DED.
“The trial was designed very well, and the results are more reliable because it’s free from commercial bias,”
said Dr. Vatinee Bunya, the Principal Investigator for DREAM’s clinical center at Scheie.
Drs. Maguire and Bunya agree that the study’s biggest challenge was the recruitment process. In addition to meeting the eligibility criteria, participants had to be willing to take five large supplements per day for a year.
“I think all of our centers found it harder to recruit than they originally thought,” said Dr. Maguire, the Principal Investigator of the coordinating center for DREAM. Although the enrollment process took longer than expected, in 2016 the DREAM clinical centers met their goal of enrolling 535 patients suffering from moderate to severe DED. Dr. Maguire noted that Scheie was one of DREAM’s highest performing centers.
The participants were divided into an experimental group and a control group. Those in the experimental group took omega-3 supplements while those in the control group took a placebo containing olive oil. The clinical trial was "masked" so that both participants and the examining physicians did not know which group each patient was in. Researchers checked in with the participants through three office visits and one phone call.
“We have 92% follow up. I feel very confident in the results that we have,” said Dr. Maguire, who added that results will be published in 2018.
Dr. Maguire explained that dry eye occurs when the lacrimal glands around the eye do not produce enough tears to keep the eyes wet and comfortable or when the tears evaporate too quickly. A lack of tears can stimulate inflammation, which can then result in even less tear production. “Dry eye is thought to be a vicious cycle,” said Dr. Maguire.
Symptoms of dry eye can include a dry, gritty, itchy, or burning sensation in the eyes. Eyes might also be red, watery, or teary, and many people report the feeling of something in the eye or eye strain.
“I think in the past it was underestimated how much dry eye affects people,” said Dr. Bunya. “While it’s not a blinding disease that will take vision away, it can have a significant impact on a patient's quality of life."
Dry eye can result from a number of causes, but aging is the single highest risk factor. As people age, they tend to produce less tears, and Dr. Bunya explained that DED has become more of a problem as the population ages. The increase in prevalence has drawn attention to DED as an area in need of more research.
“In recent years, more and more people are becoming interested in dry eye and in finding better ways to treat the disease,” said Dr. Bunya. “It’s one of the most common reasons why people go to the eye doctor.
”The findings of the DREAM study will have implications for both patient management and for the understanding of dry eye’s etiology. While opinion is currently split among ophthalmologists over whether or not omega-3s are effective for the treatment for dry eye, the results of DREAM will either give credence to or contest their efficacy, guiding future prescriptions.
“I think we’ll learn a lot from the DREAM study not only about the effect of omega-3 fatty acids, but also about the natural history of dry eye,” said Dr. Bunya. “Wewill learn valuable information about how the symptoms and eye exam findings of the patients in the placebo group changed over the course of the study without treatment.”
Results from the DREAM study will be published in early 2018.