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Dry EyePhase 3DREAMNCT02128763

Dry Eye Assessment and Management Study

A Phase 3 study testing Omega-3 supplements in people with Dry Eye, run by University of Pennsylvania at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
Omega-3 supplements
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
535 participants
Where
27 sitesUnited States
Study dates
Nov 2014to 31 Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • University of Michigan Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Milton M. Hom, OD, FAAO

    Azusa, California, 91702

  • University of California, Berkeley

    Berkeley, California, 94720

  • Minnesota Eye Consultants, P.A.

    Bloomington, Minnesota, 55431

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • University of Illinois Hospital & Health Sciences

    Chicago, Illinois, 60612

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Mulqueeny Eye Centers

    Creve Coeur, Missouri, 63141

  • Price Vision Group

    Indianapolis, Indiana, 46260

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Silverstein Eye Centers

    Kansas City, Missouri, 64133

  • Northeast Ohio Eye Surgeons

    Kent, Ohio, 44240

  • Shettle Eye Research

    Largo, Florida

  • Southern College of Optometry

    Memphis, Tennessee, 38104

  • Eye Care Centers Management, Inc.

    Morrow, Georgia, 30260

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Pendleton Eye Center

    Oceanside, California, 92056

  • Scheie Eye Institute, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • KU Eye Center

    Prairie Village, Kansas, 66208

  • The Eye Centers of Racine and Kenosha

    Racine, Wisconsin, 53405

  • Oculus Research at Garner at Eyecarecenter

    Raleigh, North Carolina, 27603

  • Universtity of Rochester-Flaum Eye Institute

    Rochester, New York, 14642

  • Stephen Cohen, OD PC

    Scottsdale, Arizona, 85254

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Wolstan and Goldberg Eye Associates

    Torrance, California, 90505

  • Clinical Eye Research of Boston

    Winchester, Massachusetts, 01890

Other trials in United States

About this study

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.

Read the 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.
Conditions
Dry Eye
Being tested
Omega-3 supplements, Placebo
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 supplementsDrug

    2000 mg EPA and 1000 mg DHA per day

  • PlaceboDrug

    Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Study groups in NCT02128763
Study groupRoleWhat they receive
Omega-3 supplementsExperimentalTotal 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
Receives: Drug: Omega-3 supplements
PlaceboPlacebo comparatorOlive oil-5 gelcaps per day
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (13)

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

  10. 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.

    Measured: 12 months

  11. 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.

    Measured: 12 months

  12. 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.

    Measured: 12 months

  13. 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.,(%)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion5 Sep 2017
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
535 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128763
Sponsor's protocol ID
UPenn IRB Protocol 816490
Other IDs
U10EY022879, U10EY022881
Acronym
DREAM
Status last verified
Jun 2022
First submitted
28 Apr 2014
Last updated
19 Jul 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30161055

  • 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.

    PubMed 31022469

  • 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.

    PubMed 31445751

  • 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.

    PubMed 31489258

  • 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.

    PubMed 32097181

  • 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.

    PubMed 32821497

  • 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.

    PubMed 39079754

  • 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.

    PubMed 38391283

  • 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.

    PubMed 38345056

  • 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.

    PubMed 36575626

  • 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.

    PubMed 34294637

  • 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.

    PubMed 33290317

  • 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.

    PubMed 31425752

  • 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.

    PubMed 31116166

  • 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.

    PubMed 29883769

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega-3 supplements in people with Dry Eye, run by University of Pennsylvania at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128763, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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