The DREAM Study is the first large scale, multicenter, double masked randomized controlled trial (RCT) using Omega-3 for DED. The DREAM Study design of a twelve-month primary RCT trial followed by a twelve-month extension study enables us to have an assessment over time of DED in a group of well-characterized subjects . The results obtained from DREAM will help us better understand and describe DED itself and specifically determine the efficacy and safety of the use of Omega-3 in treatment of DED.
- This Dry Eye Assessment and Management (DREAM) study will include patients with moderate to severe dry eye disease. Patients are enrolled recruited through approximately 25 clinical centers led by an ophthalmologist or an optometrist. The National Eye Institute, National Institutes of Health, Department of Health and Human Services provides funding for DREAM.
- This study includes patients with dry eye disease of varying severity levels since we believe that Omega-3 (ω3) fatty acids supplementation has the potential to provide benefits to most individuals suffering from this disease.
- Individual patients will be followed for at least one year, with the option to continue into a second year if they are taking the active supplement rather than the placebo.
- Patients will be randomly assigned to receive either Omega-3 (active) or olive oil (placebo)
- Patients have a 2 out of 3 chance of getting the Omega 3 supplements and a 1 out of 3 chance of getting the placebo.
- Participants will take 5 capsules a day for 1 year
- 5 visits and 1 phone call over one year
DREAM is a research study involving 600 patients and approximately 25 eye centers across the United States. Its purpose is to compare Omega‐3 fatty acids, an over‐the‐counter nutritional supplement, vs. placebo (olive oil) in people with dry eye disease. Although some patients with dry eye disease use these supplements to relieve their symptoms, the use of Omega 3 in treating dry eye disease has not been established and is experimental in this study.
The purpose of the DREAM Study is to determine the safety and efficacy of the use of Omega-3 in treating dry eye disease. It will test the effectiveness of Omega 3 supplementation for the first time in a large, well-characterized, double-blind clinical trial and establish the scientific outcomes of such treatment and improve our ability to diagnose and treat patients with dry eye disease.
- It is important to know that you may not get any benefit from taking part in this research.
- However, possible benefits may be relief from your symptoms associated with dry eye disease, such as, irritation, foreign-body sensation, itching, burning, and blurred vision.
- Your participation in this study will help eye care clinicians and scientists diagnose and monitor dry eye disease more effectively and will help future dry eye research and future treatment for patients with dry eyes.
The Study Chair of the DREAM Study is Penny A. Asbell, M.D., Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai in New York City. Maureen Maguire, Ph.D, Professor of Ophthalmology at the Perlman School of Medicine at the University of Pennsylvania School of Medicine and Director of the Center for Preventive Ophthalmology & Biostatistics (CPOB) is Principal Investigator of the DREAM Study coordinating Center, at which all the study data are analyzed.
DREAM is funded by the National Eye Institute, a branch of the National Institutes of Health, an agency within the U.S. Government.