Dry Eye Assessment and Management Study

Dry Eye Clinical Trial

— DREAM  

Official title:

Dry Eye Assessment and Management Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128763
• Other study ID #: UPenn IRB Protocol 816490
• Secondary ID: U10EY022879U10EY
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: January 31, 2020
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan
United States	Milton M. Hom, OD, FAAO	Azusa	California
United States	University of California, Berkeley	Berkeley	California
United States	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Illinois Hospital & Health Sciences	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Mulqueeny Eye Centers	Creve Coeur	Missouri
United States	Price Vision Group	Indianapolis	Indiana
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Tauber Eye Center	Kansas City	Missouri
United States	Northeast Ohio Eye Surgeons	Kent	Ohio
United States	Shettle Eye Research	Largo	Florida
United States	Southern College of Optometry	Memphis	Tennessee
United States	Eye Care Centers Management, Inc.	Morrow	Georgia
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Pendleton Eye Center	Oceanside	California
United States	Scheie Eye Institute, University of Pennsylvania	Philadelphia	Pennsylvania
United States	KU Eye Center	Prairie Village	Kansas
United States	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	Oculus Research at Garner at Eyecarecenter	Raleigh	North Carolina
United States	Universtity of Rochester-Flaum Eye Institute	Rochester	New York
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Stephen Cohen, OD PC	Scottsdale	Arizona
United States	Wolstan and Goldberg Eye Associates	Torrance	California
United States	Clinical Eye Research of Boston	Winchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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 — View 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. d — View 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 clini — View 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 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Intraocular Pressure (IOP)- mm Hg	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
Other	Change in Tear Break up Time by Keratography	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
Other	Change in Tear Meniscus Height( TMH) by Keratography	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
Other	Change in Redness by Keratography	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
Other	Change in Tear Osmolarity	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
Primary	Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 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	Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)	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
Secondary	Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale	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
Secondary	Change From Baseline in SF-36 Physical Health Subscale	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
Secondary	Change From Baseline in SF-36 Mental Health Subscale	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
Secondary	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA	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
Secondary	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA	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
Secondary	Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid	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
Secondary	Change in Conjunctival Staining Score	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
Secondary	Change in Schirmer's Test mm	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
Secondary	Change in Tear Film Break up Time, in Seconds	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
Secondary	Change in Corneal Fluorescein Staining Score	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
Secondary	Change in Visual Acuity	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
Secondary	Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease	Subjects with change in number of treatments used for dry eye disease, n.,(%)	12 months