Dry Eye Assessment and Management Study (DREAM)

June 23, 2022 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

535

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
      • Scottsdale, Arizona, United States, 85254
        • Stephen Cohen, OD PC
    • California
      • Azusa, California, United States, 91702
        • Milton M. Hom, OD, FAAO
      • Berkeley, California, United States, 94720
        • University of California, Berkeley
      • Oceanside, California, United States, 92056
        • Pendleton Eye Center
      • Torrance, California, United States, 90505
        • Wolstan and Goldberg Eye Associates
    • Florida
      • Largo, Florida, United States
        • Shettle Eye Research
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Eye Care Centers Management, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital & Health Sciences
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • KU Eye Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Winchester, Massachusetts, United States, 01890
        • Clinical Eye Research of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan Kellogg Eye Center
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants, P.A.
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Mulqueeny Eye Centers
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Centers
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • Universtity of Rochester-Flaum Eye Institute
    • North Carolina
      • Raleigh, North Carolina, United States, 27603
        • Oculus Research at Garner at Eyecarecenter
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Kent, Ohio, United States, 44240
        • Northeast Ohio Eye Surgeons
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute, University of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Southern College of Optometry
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • The Eye Centers of Racine and Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 supplements
Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
Drug: Omega-3 supplements
2000 mg EPA and 1000 mg DHA per day
Placebo Comparator: Placebo
Olive oil-5 gelcaps per day
Drug: Placebo
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
Time Frame: 12 months
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.
12 months
Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
Time Frame: 12 months
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.
12 months
Change From Baseline in SF-36 Physical Health Subscale
Time Frame: 12 months
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.
12 months
Change From Baseline in SF-36 Mental Health Subscale
Time Frame: 12 months
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.
12 months
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
Time Frame: 12 months
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.
12 months
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
Time Frame: 12 months
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.
12 months
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
Time Frame: 12 months
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.
12 months
Change in Conjunctival Staining Score
Time Frame: 12 months
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.
12 months
Change in Schirmer's Test mm
Time Frame: 12 months
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.
12 months
Change in Tear Film Break up Time, in Seconds
Time Frame: 12 months
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.
12 months
Change in Corneal Fluorescein Staining Score
Time Frame: 12 months
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.
12 months
Change in Visual Acuity
Time Frame: 12 months
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.
12 months
Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
Time Frame: 12 months
Subjects with change in number of treatments used for dry eye disease, n.,(%)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure (IOP)- mm Hg
Time Frame: 12 months
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.
12 months
Change in Tear Break up Time by Keratography
Time Frame: 12 months
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.
12 months
Change in Tear Meniscus Height( TMH) by Keratography
Time Frame: 12 months
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.
12 months
Change in Redness by Keratography
Time Frame: 12 months
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).
12 months
Change in Tear Osmolarity
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Eye Institute (NEI)

Investigators

  • Study Chair: Penny A Asbell, MD, University of Tennessee Health Science Center
  • Principal Investigator: Maureen G Maguire, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

September 5, 2017

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPenn IRB Protocol 816490
  • U10EY022879 (U.S. NIH Grant/Contract)
  • U10EY022881 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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