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Dry Eye Assessment and Management Study (DREAM)

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Omega-3 supplements
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Stephen Cohen, OD PC
  • Mayo Clinic Arizona
  • Milton M. Hom, OD, FAAO
  • University of California, Berkeley
  • Pendleton Eye Center
  • Wolstan and Goldberg Eye Associates
  • Shettle Eye Research
  • Eye Care Centers Management, Inc.
  • University of Illinois Hospital & Health Sciences
  • Price Vision Group
  • KU Eye Center
  • Tufts Medical Center
  • Massachusetts Eye and Ear Infirmary
  • Clinical Eye Research of Boston
  • University of Michigan Kellogg Eye Center
  • Minnesota Eye Consultants, P.A.
  • Mulqueeny Eye Centers
  • Tauber Eye Center
  • Silverstein Eye Centers
  • Icahn School of Medicine at Mount Sinai
  • Universtity of Rochester-Flaum Eye Institute
  • Oculus Research at Garner at Eyecarecenter
  • Case Western Reserve University
  • Northeast Ohio Eye Surgeons
  • Scheie Eye Institute, University of Pennsylvania
  • Southern College of Optometry
  • The Eye Centers of Racine and Kenosha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 supplements

Placebo

Arm Description

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

Olive oil-5 gelcaps per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the 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. A negative change score = improvement.
Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement.
Change From Baseline in SF-36 Physical Health Subscale
Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Change From Baseline in SF-36 Mental Health Subscale
Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn.
Change in Conjunctival Staining Score
Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement.
Change in Schirmer's Test mm
The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study.
Change in Tear Film Break up Time, in Seconds
Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement.
Change in Corneal Fluorescein Staining Score
Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement.
Change in Visual Acuity
Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity.
Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
Subjects with change in number of treatments used for dry eye disease, n.,(%)

Full Information

First Posted
April 28, 2014
Last Updated
June 23, 2022
Sponsor
University of Pennsylvania
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02128763
Brief Title
Dry Eye Assessment and Management Study
Acronym
DREAM
Official Title
Dry Eye Assessment and Management Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 5, 2017 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study is designed to: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 supplements
Arm Type
Experimental
Arm Description
Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olive oil-5 gelcaps per day
Intervention Type
Drug
Intervention Name(s)
Omega-3 supplements
Intervention Description
2000 mg EPA and 1000 mg DHA per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
Primary Outcome Measure Information:
Title
Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
Description
Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the 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. A negative change score = improvement.
Time Frame
12 months
Title
Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
Description
Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement.
Time Frame
12 months
Title
Change From Baseline in SF-36 Physical Health Subscale
Description
Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Time Frame
12 months
Title
Change From Baseline in SF-36 Mental Health Subscale
Description
Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.
Time Frame
12 months
Title
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
Description
Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit.
Time Frame
12 months
Title
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
Description
Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.
Time Frame
12 months
Title
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
Description
Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn.
Time Frame
12 months
Title
Change in Conjunctival Staining Score
Description
Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement.
Time Frame
12 months
Title
Change in Schirmer's Test mm
Description
The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study.
Time Frame
12 months
Title
Change in Tear Film Break up Time, in Seconds
Description
Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement.
Time Frame
12 months
Title
Change in Corneal Fluorescein Staining Score
Description
Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement.
Time Frame
12 months
Title
Change in Visual Acuity
Description
Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity.
Time Frame
12 months
Title
Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
Description
Subjects with change in number of treatments used for dry eye disease, n.,(%)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change in Intraocular Pressure (IOP)- mm Hg
Description
Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure.
Time Frame
12 months
Title
Change in Tear Break up Time by Keratography
Description
Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.
Time Frame
12 months
Title
Change in Tear Meniscus Height( TMH) by Keratography
Description
The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.
Time Frame
12 months
Title
Change in Redness by Keratography
Description
Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness).
Time Frame
12 months
Title
Change in Tear Osmolarity
Description
Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny A Asbell, MD
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maureen G Maguire, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephen Cohen, OD PC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Milton M. Hom, OD, FAAO
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Facility Name
Pendleton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
Country
United States
Facility Name
Eye Care Centers Management, Inc.
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
University of Illinois Hospital & Health Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
KU Eye Center
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Eye Research of Boston
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
University of Michigan Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minnesota Eye Consultants, P.A.
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Mulqueeny Eye Centers
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Silverstein Eye Centers
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Universtity of Rochester-Flaum Eye Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Oculus Research at Garner at Eyecarecenter
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Northeast Ohio Eye Surgeons
City
Kent
State/Province
Ohio
ZIP/Postal Code
44240
Country
United States
Facility Name
Scheie Eye Institute, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
The Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30161055
Citation
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.
Results Reference
result
PubMed Identifier
31022469
Citation
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.
Results Reference
result
PubMed Identifier
31445751
Citation
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.
Results Reference
result
PubMed Identifier
31489258
Citation
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.
Results Reference
result
PubMed Identifier
32097181
Citation
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.
Results Reference
result
PubMed Identifier
32821497
Citation
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.
Results Reference
result
PubMed Identifier
34294637
Citation
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.
Results Reference
derived
PubMed Identifier
33290317
Citation
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.
Results Reference
derived
PubMed Identifier
31425752
Citation
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.
Results Reference
derived
PubMed Identifier
31116166
Citation
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.
Results Reference
derived
PubMed Identifier
29883769
Citation
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.
Results Reference
derived
PubMed Identifier
29652551
Citation
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.
Results Reference
derived

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Dry Eye Assessment and Management Study

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