NCT02128763

Brief Summary

The objective of the DREAM study is to evaluate the effectiveness and safety of supplementation with omega-3 fatty acids in relieving the symptoms of moderate to severe dry eye disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_3

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 4, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

July 19, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

April 28, 2014

Results QC Date

August 28, 2018

Last Update Submit

June 23, 2022

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months

    Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points.

    12 months

Secondary Outcomes (13)

  • Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)

    12 months

  • Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale

    12 months

  • Change From Baseline in SF-36 Physical Health Subscale

    12 months

  • Change From Baseline in SF-36 Mental Health Subscale

    12 months

  • Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA

    12 months

  • +8 more secondary outcomes

Other Outcomes (5)

  • Change in Intraocular Pressure (IOP)- mm Hg

    12 months

  • Change in Tear Break up Time by Keratography

    12 months

  • Change in Tear Meniscus Height( TMH) by Keratography

    12 months

  • +2 more other outcomes

Study Arms (2)

Omega-3 supplements

EXPERIMENTAL

Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps

Drug: Omega-3 supplements

Placebo

PLACEBO COMPARATOR

Olive oil-5 gelcaps per day

Drug: Placebo

Interventions

Omega-3 supplementsDRUG

2000 mg EPA and 1000 mg DHA per day

Omega-3 supplements
PlaceboDRUG

Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than or equal to 2 of the following 4 signs in the same eye at screening and baseline visits (Same signs must be present at Screening and Baseline visits): Conjunctival staining present greater than or equal to 1 (out of possible score of 6 per eye), Corneal fluorescein staining present greater than or equal to 4 (out of a possible score of 15 per eye), Tear film break up time (TBUT) less than or equal to 7 seconds, Schirmer's test greater than or equal to 1 to less than or equal to 7 mm in 5 minutes.
  • 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

You may not qualify if:

  • Allergic to ingredients in supplements or placebo
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Stephen Cohen, OD PC

Scottsdale, Arizona, 85254, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Milton M. Hom, OD, FAAO

Azusa, California, 91702, United States

Location

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Pendleton Eye Center

Oceanside, California, 92056, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Shettle Eye Research

Largo, Florida, United States

Location

Eye Care Centers Management, Inc.

Morrow, Georgia, 30260, United States

Location

University of Illinois Hospital & Health Sciences

Chicago, Illinois, 60612, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

KU Eye Center

Prairie Village, Kansas, 66208, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Clinical Eye Research of Boston

Winchester, Massachusetts, 01890, United States

Location

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Minnesota Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Mulqueeny Eye Centers

Creve Coeur, Missouri, 63141, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Universtity of Rochester-Flaum Eye Institute

Rochester, New York, 14642, United States

Location

Oculus Research at Garner at Eyecarecenter

Raleigh, North Carolina, 27603, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Northeast Ohio Eye Surgeons

Kent, Ohio, 44240, United States

Location

Scheie Eye Institute, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

Related Publications (16)

  • 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.

    PMID: 30161055RESULT

  • 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.

    PMID: 31022469RESULT

  • 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.

    PMID: 31445751RESULT

  • 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.

    PMID: 31489258RESULT

  • 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.

    PMID: 32097181RESULT

  • 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.

    PMID: 32821497RESULT

  • 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.

    PMID: 39079754DERIVED

  • 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.

    PMID: 38391283DERIVED

  • 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.

    PMID: 38345056DERIVED

  • 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.

    PMID: 36575626DERIVED

  • 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.

    PMID: 34294637DERIVED

  • 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.

    PMID: 33290317DERIVED

  • 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.

    PMID: 31425752DERIVED

  • 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.

    PMID: 31116166DERIVED

  • 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.

    PMID: 29883769DERIVED

  • 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.

    PMID: 29652551DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Maureen G. Maguire, PhD
Organization
University of Pennsylvania
maguirem@pennmedicine.upenn.edu
215-615-1501

Study Officials

  • Penny A Asbell, MD

    University of Tennessee

    STUDY CHAIR

  • Maureen G Maguire, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 1, 2014

Study Start

November 1, 2014

Primary Completion

September 5, 2017

Study Completion

January 31, 2020

Last Updated

July 19, 2022

Results First Posted

January 4, 2019

Record last verified: 2022-06

Locations

US(27)