Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
535 participants
INTERVENTIONAL
2014-11-30
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
NCT01107964
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease
NCT02260960
Dry Eye Assessment and Management: Feasibility Study
NCT01102257
Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
NCT04181593
Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
NCT02980224
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Test the hypothesis that omega-3 supplementation is an effective treatment for Dry Eye Disease (DED) in Primary Clinical Trial.
* Better understand DED by describing and evaluating a comprehensive set of features of DED and treatment over 12 months of observation in a well-characterized group of patients.
* Determine the effects of extended use and discontinuation of omega-3 through the Extension trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Omega-3 supplements
Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
Omega-3 supplements
2000 mg EPA and 1000 mg DHA per day
Placebo
Olive oil-5 gelcaps per day
Placebo
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omega-3 supplements
2000 mg EPA and 1000 mg DHA per day
Placebo
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ocular Surface Disease Index (OSDI) score: 25-80 at screening, 21-80 at baseline.
* Symptoms of DED for greater than or equal to 6 months.
* Use of or desire to use artificial tears at least 2 times per day in preceding 2 weeks.
* Ability to swallow large, soft gelcaps
Exclusion Criteria
* Contact lens wear
* Pregnant, nursing, or lactating
* Current ocular infection, inflammation, or acute allergic conjunctivitis
* History of: ocular herpetic keratitis, ocular surgery in past 6 months, LASIK surgery, use of glaucoma medicine or surgery for glaucoma, liver disease, atrial fibrillation, hemophilia or bleeding tendencies
* Currently on anticoagulation therapy
* Eyelid abnormalities or extensive ocular scarring
* Use of EPA/DHA supplements in excess of 1200 mg per dayi
* Current use, insufficient washout period, or intent to change specific treatments for dry eye disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Eye Institute (NEI)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Penny A Asbell, MD
Role: STUDY_CHAIR
University of Tennessee
Maureen G Maguire, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stephen Cohen, OD PC
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Milton M. Hom, OD, FAAO
Azusa, California, United States
University of California, Berkeley
Berkeley, California, United States
Pendleton Eye Center
Oceanside, California, United States
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Shettle Eye Research
Largo, Florida, United States
Eye Care Centers Management, Inc.
Morrow, Georgia, United States
University of Illinois Hospital & Health Sciences
Chicago, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
KU Eye Center
Prairie Village, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States
Mulqueeny Eye Centers
Creve Coeur, Missouri, United States
Tauber Eye Center
Kansas City, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Universtity of Rochester-Flaum Eye Institute
Rochester, New York, United States
Oculus Research at Garner at Eyecarecenter
Raleigh, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Northeast Ohio Eye Surgeons
Kent, Ohio, United States
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Southern College of Optometry
Memphis, Tennessee, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bunya VY, Ying GS, Maguire MG, Kuklinski E, Lin MC, Peskin E, Asbell PA; DREAM Study Research Group. Prevalence of Novel Candidate Sjogren Syndrome Autoantibodies in the Dry Eye Assessment and Management (DREAM) Study. Cornea. 2018 Nov;37(11):1425-1430. doi: 10.1097/ICO.0000000000001714.
Daniel E, Maguire MG, Pistilli M, Bunya VY, Massaro-Giordano GM, Smith E, Kadakia PA, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Grading and baseline characteristics of meibomian glands in meibography images and their clinical associations in the Dry Eye Assessment and Management (DREAM) study. Ocul Surf. 2019 Jul;17(3):491-501. doi: 10.1016/j.jtos.2019.04.003. Epub 2019 Apr 22.
Oydanich M, Maguire MG, Pistilli M, Hamrah P, Greiner JV, Lin MC, Asbell PA; Dry Eye Assessment and Management Study Research Group. Effects of Omega-3 Supplementation on Exploratory Outcomes in the Dry Eye Assessment and Management Study. Ophthalmology. 2020 Jan;127(1):136-138. doi: 10.1016/j.ophtha.2019.07.009. Epub 2019 Jul 25.
Roy NS, Wei Y, Yu Y, Ying GS, Kuklinski E, Barry B, Maguire MG, Dana R, Brightwell-Arnold M, Asbell PA; for the Dry Eye Assessment and Management (DREAM) Study Group. Conjunctival HLA-DR Expression and Its Association With Symptoms and Signs in the DREAM Study. Transl Vis Sci Technol. 2019 Aug 21;8(4):31. doi: 10.1167/tvst.8.4.31. eCollection 2019 Jul.
Kuklinski EJ, Hom MM, Ying GS, Lin MC, Chapkin RS, Jones R, Moser A, Kim KY, Maguire MG, Asbell PA; DREAM Study Research Group. Associations Between Systemic Omega-3 Fatty Acid Levels With Moderate-to-Severe Dry Eye Disease Signs and Symptoms at Baseline in the Dry Eye Assessment and Management Study. Eye Contact Lens. 2021 Jan 1;47(1):2-7. doi: 10.1097/ICL.0000000000000687.
Berg EJ, Ying GS, Maguire MG, Sheffield PE, Szczotka-Flynn LB, Asbell PA, Shen JF; DREAM Study Research Group. Climatic and Environmental Correlates of Dry Eye Disease Severity: A Report From the Dry Eye Assessment and Management (DREAM) Study. Transl Vis Sci Technol. 2020 Apr 29;9(5):25. doi: 10.1167/tvst.9.5.25. eCollection 2020 Apr.
Zhong A, Augello P, Asbell P, Ying GS; DREAM Study Research Group. Intereye Agreement in Dry-Eye Signs in the DREAM Study: Implications for Future Dry-Eye Trials. Cornea. 2025 Feb 1;44(2):149-156. doi: 10.1097/ICO.0000000000003605. Epub 2024 Jul 30.
Lee DC, Guo M, Yu Y, Bunya VY, Asbell P, Ying GS. Two-Year Progression of Dry Eye Disease in Dry Eye Assessment and Management Study. Cornea. 2024 Oct 1;43(10):1231-1237. doi: 10.1097/ICO.0000000000003503. Epub 2024 Feb 22.
Hashemi MH, Ambrus JL Jr, Shukla AA, Zhu D, Ying GS, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Association of Systemic Markers of Inflammation with Signs and Symptoms of Dry Eye Disease and Sjogren's Syndrome in the Dry Eye Assessment and Management (DREAM(c)) Study. Curr Eye Res. 2024 Jun;49(6):574-581. doi: 10.1080/02713683.2024.2312937. Epub 2024 Feb 12.
Zhao M, Yu Y, Roy NS, Ying GS, Asbell P, Bunya VY. Sex-related differences and hormonal effects in the Dry Eye Assessment and Management (DREAM) study. Br J Ophthalmol. 2023 Dec 18;108(1):23-29. doi: 10.1136/bjo-2022-322238.
Sutphin JE, Ying GS, Bunya VY, Yu Y, Lin MC, McWilliams K, Schmucker E, Kuklinski EJ, Asbell PA, Maguire MG; Dry Eye Assessment and Management (DREAM) Study Research Group. Correlation of Measures From the OCULUS Keratograph and Clinical Assessments of Dry Eye Disease in the Dry Eye Assessment and Management Study. Cornea. 2022 Jul 1;41(7):845-851. doi: 10.1097/ICO.0000000000002804. Epub 2021 Jul 21.
Sayegh RR, Yu Y, Farrar JT, Kuklinski EJ, Shtein RM, Asbell PA, Maguire MG; Dry Eye Assessment and Management (DREAM) Study Research Group. Ocular Discomfort and Quality of Life Among Patients in the Dry Eye Assessment and Management Study. Cornea. 2021 Jul 1;40(7):869-876. doi: 10.1097/ICO.0000000000002580.
Hussain M, Shtein RM, Pistilli M, Maguire MG, Oydanich M, Asbell PA; DREAM Study Research Group. The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease. Ocul Surf. 2020 Jan;18(1):47-55. doi: 10.1016/j.jtos.2019.08.002. Epub 2019 Aug 16.
Szczotka-Flynn LB, Maguire MG, Ying GS, Lin MC, Bunya VY, Dana R, Asbell PA; Dry Eye Assessment and Management (DREAM) Study Research Group. Impact of Dry Eye on Visual Acuity and Contrast Sensitivity: Dry Eye Assessment and Management Study. Optom Vis Sci. 2019 Jun;96(6):387-396. doi: 10.1097/OPX.0000000000001387.
Asbell PA, Maguire MG, Peskin E, Bunya VY, Kuklinski EJ; Dry Eye Assessment and Management (DREAM(c)) Study Research Group. Dry Eye Assessment and Management (DREAM(c)) Study: Study design and baseline characteristics. Contemp Clin Trials. 2018 Aug;71:70-79. doi: 10.1016/j.cct.2018.06.002. Epub 2018 Jun 6.
Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.