Dr. Bunya and Dr. Massaro examine a patient.
By Nora Laberee
Scheie Vision Annual Report 2018
In 2014, the Dry Eye Assessment and Management (DREAM) study began to screen and recruit patients for a clinical trial testing the efficacy and safety of fish oil (omega-3 fatty acids) as a treatment for dry eye disease. The results, recently published in the New England Journal of Medicine, show no evidence of benefit or reduced symptoms from the use of omega-3 fatty acids.
Dry eye disease (DED) affects an estimated 3.2 million women and 1.68 million men over the age of 50 in the United States, according to the American Academy of Ophthalmology. This chronic condition causes ocular discomfort and visual disturbances that can significantly reduce quality of life. Doctors often advise or prescribe the use of omega-3 fatty acids to relieve these symptoms, and it is common practice for patients to take these supplements as part of their treatment.
The results of the DREAM study suggest this practice may not be as effective as originally believed. An $8 million grant from the National Eye Institute (NEI) allowed a team made up of 25 different centers across the US to participate in this double-blind clinical trial. Over a 12-month period, participants took daily oral supplements of 3000 mg of n-3 fatty acids (omega-3 fatty acids), or an olive oil placebo. The results show that the change in dry eye symptoms between the active group and the placebo group was not significantly different.
Giacomina Massaro-Giordano, MD, Vatinee Bunya, MD, and Maureen Maguire, PhD, the leads for this study at Scheie, all agreed that they did not expect the results that came out of the study. “As clinicians, we were surprised,” said Dr. Massaro. Omega-3 fatty acids are not usually the primary treatment for dry eye, but are often recommended in addition to a more central line of treatment like eye drops or prescription medications. Now, the team’s data suggesting that omega-3’s do not alleviate symptoms may impact the recommendation practices of many ophthalmologists, whether involved in the study or not.
“I always tell patients about the results of the study, whether or not they ask about them. Although, a lot of patients have heard about the results,” said Dr. Bunya, the Principal Investigator for the DREAM clinical center at Scheie.
“This should make people think much more seriously about whether or not they’re going to advise their patients to take fish oil (omega-3’s),” Dr. Maguire added. “There are a large variety of other treatments available.”
Dr. Bunya also pointed out how the cost of omega-3 supplements is high enough to be a significant factor in some patient practices. “Some patients have stopped taking the supplement because they found out the results of the study and it was too expensive for them to keep using it, while others have chosen to keep using it because they really feel like it helps them. But I think cost does play a role.” This study may change how clinicians discuss these supplements with their patients. Patients who are comfortable with the cost and feel they receive a benefit from the supplements may continue to use them.
The investigators involved in the DREAM study are already thinking about how to further study the disease. As a biostatistician at Penn Medicine, and the Principal Investigator of the coordinating center for DREAM, Dr. Maguire looks forward to further studying the data and researching the causes and treatments of dry eye. Dr. Massaro emphasizes the need for the various forms of dry eye to be better categorized, so they can each be studied individually. “There is a broad spectrum of patients with dry eye disease,” Dr. Maguire said. While the doctors agree that further categorization is necessary, Dr. Maguire pointed out that no subgroups from the initial study were found to benefit from the supplements any more than others.