Dry Eye Assessment and Management Study (DREAM)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Eye Institute (NEI)

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02128763

First received: April 28, 2014

Last updated: May 1, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2014

Last Updated Date

May 1, 2017

Start Date ^ICMJE

November 2014

Estimated Primary Completion Date

October 30, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02128763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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 ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dry Eye Assessment and Management Study

Official Title ^ICMJE

Dry Eye Assessment and Management Study

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye

Intervention ^ICMJE

Drug: Omega-3 supplements
2000 mg EPA and 1000 mg DHA per day
Drug: Placebo
Olive oil gelcaps manufactured to mimic Omega-3 gelcaps

Study Arms

Experimental: Omega-3 supplements
Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps

Intervention: Drug: Omega-3 supplements
Placebo Comparator: Placebo
Olive oil-5 gelcaps per day

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

535

Estimated Completion Date

November 2017

Estimated Primary Completion Date

October 30, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02128763

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

National Eye Institute (NEI)

Investigators ^ICMJE

Study Chair:	Penny A Asbell, MD	Mount Sinai Icahn School of Medicine
Principal Investigator:	Maureen G Maguire, PhD	University of Pennsylvania

PRS Account

University of Pennsylvania

Verification Date

May 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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