Dry Eye Assessment and Management Study
- Registration Number
- NCT02128763
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Olive oil-5 gelcaps per day Omega-3 supplements Omega-3 supplements Total 2000 mg EPA and 1000 mg DHA per day taken in 5 gelcaps
- Primary Outcome Measures
Name Time Method Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months 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.
- Secondary Outcome Measures
Name Time Method Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms) 12 months 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.
Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale 12 months 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.
Change From Baseline in SF-36 Physical Health Subscale 12 months 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.
Change From Baseline in SF-36 Mental Health Subscale 12 months 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.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA 12 months 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.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA 12 months 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.
Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid 12 months 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.
Change in Conjunctival Staining Score 12 months 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.
Change in Schirmer's Test mm 12 months 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.
Change in Tear Film Break up Time, in Seconds 12 months 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.
Change in Corneal Fluorescein Staining Score 12 months 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.
Change in Visual Acuity 12 months 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.
Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease 12 months Subjects with change in number of treatments used for dry eye disease, n.,(%)
Trial Locations
- Locations (27)
Stephen Cohen, OD PC
🇺🇸Scottsdale, Arizona, United States
The Eye Centers of Racine and Kenosha
🇺🇸Racine, Wisconsin, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Scheie Eye Institute, University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northeast Ohio Eye Surgeons
🇺🇸Kent, Ohio, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Universtity of Rochester-Flaum Eye Institute
🇺🇸Rochester, New York, United States
Milton M. Hom, OD, FAAO
🇺🇸Azusa, California, United States
Oculus Research at Garner at Eyecarecenter
🇺🇸Raleigh, North Carolina, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Clinical Eye Research of Boston
🇺🇸Winchester, Massachusetts, United States
Pendleton Eye Center
🇺🇸Oceanside, California, United States
Wolstan and Goldberg Eye Associates
🇺🇸Torrance, California, United States
University of California, Berkeley
🇺🇸Berkeley, California, United States
University of Illinois Hospital & Health Sciences
🇺🇸Chicago, Illinois, United States
Eye Care Centers Management, Inc.
🇺🇸Morrow, Georgia, United States
KU Eye Center
🇺🇸Prairie Village, Kansas, United States
Minnesota Eye Consultants, P.A.
🇺🇸Bloomington, Minnesota, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States
Mulqueeny Eye Centers
🇺🇸Creve Coeur, Missouri, United States
Southern College of Optometry
🇺🇸Memphis, Tennessee, United States
University of Michigan Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States