Dry Eye Assessment and Management Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-001761
NCT ID: NCT02128763
Sponsor Protocol Number: 816490
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Joanne Shen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available