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Dry Eye Assessment and Management Study (DREAM)

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ClinicalTrials.gov Identifier: NCT02128763
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Omega-3 supplements Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Eye Assessment and Management Study
Study Start Date : November 2014
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : November 2017

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




Primary Outcome Measures :
  1. Mean of change from baseline in OSDI score at 6 and 12 months (Primary Trial). Mean of change from 12 months in OSDI score at 18 and 24 months (Extension Study) [ Time Frame: 12 months and 24 months ]

Secondary Outcome Measures :
  1. Compliance with the study treatment protocol as measured by changes in blood levels of fatty acids and pill counts [ Time Frame: 12 and 24 months ]
  2. Greater than or equal to 10 point change in OSDI [ Time Frame: 12 and 24 months ]
  3. Change in conjunctival staining score [ Time Frame: 12 and 24 months ]
  4. Change in corneal fluorescein staining score [ Time Frame: 12 and 24 months ]
  5. Change in tear film break up time [ Time Frame: 12 and 24 months ]
  6. Change in Schirmer's test mm [ Time Frame: 12 and 24 months ]
  7. Change in use of artificial tears and other treatments for dry eye disease [ Time Frame: 12 and 24 months ]
  8. Change in SF-36 score [ Time Frame: 12 and 24 months ]
  9. Change in the Brief Ocular Discomfort Index score [ Time Frame: 12 and 24 months ]
  10. Change in healthcare utilization costs [ Time Frame: 12 and 24 months ]
  11. Difference in cost effectiveness between groups on active and placebo supplements [ Time Frame: 12 and 24 months ]

Other Outcome Measures:
  1. Incidence of ocular and systemic adverse events [ Time Frame: 12 and 24 months ]
  2. Change in visual acuity [ Time Frame: 12 and 24 months ]
  3. Change in IOP [ Time Frame: 12 and 24 months ]
  4. Change in contrast sensitivity [ Time Frame: 12 and 24 months ]
  5. Change in meibomian gland secretion [ Time Frame: 12 and 24 months ]
  6. Change in tear break up time by keratography [ Time Frame: 12 and 24 months ]
  7. Change in tear meniscus height by keratography [ Time Frame: 12 and 24 months ]
  8. Change in redness by keratography [ Time Frame: 12 and 24 months ]
  9. Change in meibography by keratography [ Time Frame: 12 and 24 months ]
  10. Change in tear osmolarity [ Time Frame: 12 and 24 months ]
  11. Change in tear cytokine level [ Time Frame: 12 and 24 months ]
  12. Change in ocular surface cell HLA-DR expression [ Time Frame: 12 and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128763


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