Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study
Overview
- Phase
- Phase 2
- Intervention
- Omega-3 EFA Supplement
- Conditions
- Dry Eye Syndromes
- Sponsor
- Asbell, Penny, M.D.
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change on Ocular Surface Disease Index (OSDI)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. Inflammation may be an important component of this disease. This is supported by the observation that cyclosporine, a drug that targets the immune system, is approved for and effectively treats DED. Inflammatory processes likely produce ocular surface damage and contribute to chronic DED. Because not all people with DED respond to current anti-inflammatory treatments, other immune-modulating treatments would be of value. Furthermore, despite a great deal of evidence supporting DED as an inflammatory disease, not all researchers currently agree with this classification. More data that specifically measures inflammatory responses in DED needs to be collected in a well-characterized patient population and correlated with signs and symptoms of DED in order to improve our understanding and classification of the disease. Essential Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease treatment has resulted in several small studies as well as the use (and over-the-counter availability) of EFA-containing nutritional supplements, including several specifically for the treatment of DED. Despite this interest in EFA for DED, there are no strong empirical data from a well-controlled randomized controlled trial RCT supporting the use of EFA for DED. We postulate that DED is an inflammatory disease and hypothesize that EFA can mediate immune responses, thus improving DED signs, symptoms and associated measures of inflammation. The proposed three month feasibility study allows us the chance to demonstrate our ability to successfully execute our own protocol with compliance from the study patients before we begin the process of initiating a full-scale multi-center trial.
Investigators
Penny Asbell
Professor
Asbell, Penny, M.D.
Eligibility Criteria
Inclusion Criteria
- •Sign and date the informed consent form approved by the IRB.
- •≥ 18 years of age
- •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).
- •Conjunctival staining present ≥ 1
- •Corneal fluorescein staining present ≥ 1
- •Tear film break up time (TFBUT) ≤ 7 seconds
- •Schirmer test ≤ 7 mm/5min
- •Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).
- •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.
- •Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.
Exclusion Criteria
- •Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).
- •Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
- •History of ocular herpetic keratitis.
- •Eye surgery (including cataract surgery) within 6 months prior to randomization.
- •Previous LASIK surgery
- •Pregnant or nursing/lactating
- •Participation in a study of an investigational drug or device within the past 30 days.
- •Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation
- •Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
- •Contact lens wearers
Arms & Interventions
Omega-3 EFA Supplement
The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 esssential fatty acid i.e Omega-3 EFA supplement comprised of: 2000 mg EPA 1000 mg DHA
Intervention: Omega-3 EFA Supplement
Olive Oil
Gel Capsule
Intervention: Olive Oil
Outcomes
Primary Outcomes
Change on Ocular Surface Disease Index (OSDI)
Time Frame: 90 +/- 14 days following initiation of drug regimen
Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content
Time Frame: Baseline and 3 Months
Secondary Outcomes
- Change on Brief Ocular Discomfort Inventory (BODI)(90 +/- 14 days following initiation of drug regimen)
- Change on Impact of Dry Eye on Everyday Life (IDEEL)(90 +/- 14 days following initiation of drug regimen)
- Change in Quality of Life Associated With Chronic Pain(90 +/- 14 days following initiation of drug regimen)
- Change in the Ocular Surface(90 +/- 14 days following initiation of drug regimen)
- Change in Schirmer's(90 +/- 14 days following initiation of drug regimen)
- Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines(90 +/- 14 days following initiation of drug regimen)