Dry Eye Assessment and Management Study - Full Text View

Purpose

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	Intervention	Phase
Dry Eye	Drug: Omega-3 supplements Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Dry Eye Assessment and Management Study

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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:

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 ]
Greater than or equal to 10 point change in OSDI [ Time Frame: 12 and 24 months ]
Change in conjunctival staining score [ Time Frame: 12 and 24 months ]
Change in corneal fluorescein staining score [ Time Frame: 12 and 24 months ]
Change in tear film break up time [ Time Frame: 12 and 24 months ]
Change in Schirmer's test mm [ Time Frame: 12 and 24 months ]
Change in use of artificial tears and other treatments for dry eye disease [ Time Frame: 12 and 24 months ]
Change in SF-36 score [ Time Frame: 12 and 24 months ]
Change in the Brief Ocular Discomfort Index score [ Time Frame: 12 and 24 months ]
Change in healthcare utilization costs [ Time Frame: 12 and 24 months ]
Difference in cost effectiveness between groups on active and placebo supplements [ Time Frame: 12 and 24 months ]

Other Outcome Measures:

Incidence of ocular and systemic adverse events [ Time Frame: 12 and 24 months ]
Change in visual acuity [ Time Frame: 12 and 24 months ]
Change in IOP [ Time Frame: 12 and 24 months ]
Change in contrast sensitivity [ Time Frame: 12 and 24 months ]
Change in meibomian gland secretion [ Time Frame: 12 and 24 months ]
Change in tear break up time by keratography [ Time Frame: 12 and 24 months ]
Change in tear meniscus height by keratography [ Time Frame: 12 and 24 months ]
Change in redness by keratography [ Time Frame: 12 and 24 months ]
Change in meibography by keratography [ Time Frame: 12 and 24 months ]
Change in tear osmolarity [ Time Frame: 12 and 24 months ]
Change in tear cytokine level [ Time Frame: 12 and 24 months ]
Change in ocular surface cell HLA-DR expression [ Time Frame: 12 and 24 months ]


Enrollment:	535
Study Start Date:	November 2014
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	October 30, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02128763

Show 27 Study Locations

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

More Information


Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT02128763 History of Changes
Other Study ID Numbers:	UPenn IRB Protocol 816490 U10EY022879 ( U.S. NIH Grant/Contract ) U10EY022881 ( U.S. NIH Grant/Contract )
Study First Received:	April 28, 2014
Last Updated:	May 1, 2017

Additional relevant MeSH terms:


Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases	Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on July 17, 2017

Dry Eye Assessment and Management Study (DREAM)