Dry Eye Syndromes Clinical Trial
— DREAMOfficial title:
Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study
Verified date | July 2012 |
Source | Asbell, Penny, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.
Status | Completed |
Enrollment | 23 |
Est. completion date | March 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Sign and date the informed consent form approved by the IRB. 2. = 18 years of age 3. Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization). 1. Conjunctival staining present = 1 2. Corneal fluorescein staining present = 1 3. Tear film break up time (TFBUT) = 7 seconds 4. Schirmer test = 7 mm/5min 4. Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit). 5. Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months. 6. Intraocular pressure (IOP) = 5 mmHg and = 22 mmHg in each eye. 7. Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit. 8. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff. 9. Be able to swallow large, soft gelcaps Exclusion Criteria: 1. Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil). 2. Current diagnosis of ocular infection (e.g. bacterial, viral or fungal). 3. History of ocular herpetic keratitis. 4. Eye surgery (including cataract surgery) within 6 months prior to randomization. 5. Previous LASIK surgery 6. Pregnant or nursing/lactating 7. Participation in a study of an investigational drug or device within the past 30 days. 8. Recent (= 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation 9. Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation. 10. Contact lens wearers 11. Use of glaucoma medication or history of surgery for glaucoma. 12. Recent (= 3 months) insertion of punctual plugs. 13. Using punctual plugs but unwilling to commit to their use for the duration of the study. 14. Unwilling to commit to same brand of artificial tears throughout the study. 15. Current use of EPA/DHA supplements in excess of 1 gram/day. 16. Recent (= 6 months) initiation of use of Restasis. 17. Use of Restasis but unwilling to commit to use of Restasis for the duration of the study. 18. Discontinued use of Restasis within the last 3 months. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Asbell, Penny, M.D. | National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change on Ocular Surface Disease Index (OSDI) | 90 +/- 14 days following initiation of drug regimen | Yes | |
Primary | Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content | Baseline and 3 Months | No | |
Secondary | Change on Brief Ocular Discomfort Inventory (BODI) | 90 +/- 14 days following initiation of drug regimen | Yes | |
Secondary | Change on Impact of Dry Eye on Everyday Life (IDEEL) | 90 +/- 14 days following initiation of drug regimen | Yes | |
Secondary | Change in Quality of Life Associated With Chronic Pain | 90 +/- 14 days following initiation of drug regimen | Yes | |
Secondary | Change in the Ocular Surface | 90 +/- 14 days following initiation of drug regimen | Yes | |
Secondary | Change in Schirmer's | 90 +/- 14 days following initiation of drug regimen | Yes | |
Secondary | Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines | 90 +/- 14 days following initiation of drug regimen | Yes |
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