Clinical trial NCT02128763: Dry Eye Assessment and Management Study
Official title: Dry Eye Assessment and Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-05-01
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)
timeFrame: 12 months
measure: Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale
timeFrame: 12 months
measure: Change From Baseline in SF-36 Physical Health Subscale
timeFrame: 12 months
measure: Change From Baseline in SF-36 Mental Health Subscale
timeFrame: 12 months
measure: Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA
timeFrame: 12 months
measure: Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA
timeFrame: 12 months
measure: Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid
timeFrame: 12 months
measure: Change in Conjunctival Staining Score
timeFrame: 12 months
measure: Change in Schirmer's Test mm
timeFrame: 12 months
measure: Change in Tear Film Break up Time, in Seconds
timeFrame: 12 months
measure: Change in Corneal Fluorescein Staining Score
timeFrame: 12 months
measure: Change in Visual Acuity
timeFrame: 12 months
measure: Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease
timeFrame: 12 months
Other outcomes:
measure: Change in Intraocular Pressure (IOP)- mm Hg
timeFrame: 12 months
measure: Change in Tear Break up Time by Keratography
timeFrame: 12 months
measure: Change in Tear Meniscus Height( TMH) by Keratography
timeFrame: 12 months
measure: Change in Redness by Keratography
timeFrame: 12 months
measure: Change in Tear Osmolarity
timeFrame: 12 months
Locations:
city: Scottsdale
country: United States
facility: Stephen Cohen, OD PC
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO
state: California
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
city: Oceanside
country: United States
facility: Pendleton Eye Center
state: California
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Prairie Village
country: United States
facility: KU Eye Center
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Winchester
country: United States
facility: Clinical Eye Research of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, P.A.
state: Minnesota
city: Creve Coeur
country: United States
facility: Mulqueeny Eye Centers
state: Missouri
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: Universtity of Rochester-Flaum Eye Institute
state: New York
city: Raleigh
country: United States
facility: Oculus Research at Garner at Eyecarecenter
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Kent
country: United States
facility: Northeast Ohio Eye Surgeons
state: Ohio
city: Philadelphia
country: United States
facility: Scheie Eye Institute, University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: University of Tennessee
name: Penny A Asbell, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Maureen G Maguire, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Dry Eye Assessment and Management Study Research Group; Asbell PA, Maguire MG, Pistilli M, Ying GS, Szczotka-Flynn LB, Hardten DR, Lin MC, Shtein RM. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690. doi: 10.1056/NEJMoa1709691. Epub 2018 Apr 13.