Clinical trial NCT01102257: Dry Eye Assessment and Management: Feasibility Study
Official title: Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keywords: Dry Eye Disease
DED
Keratoconjunctivitis Sicca
Omega-3
Lead sponsor: Asbell, Penny, M.D.
Sponsor class: INDIV
Collaborators: name: National Eye Institute (NEI)
First posted: 2010-04-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change on Ocular Surface Disease Index (OSDI)
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content
timeFrame: Baseline and 3 Months
Secondary outcomes:
measure: Change on Brief Ocular Discomfort Inventory (BODI)
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change on Impact of Dry Eye on Everyday Life (IDEEL)
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change in Quality of Life Associated With Chronic Pain
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change in the Ocular Surface
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change in Schirmer's
timeFrame: 90 +/- 14 days following initiation of drug regimen
measure: Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines
timeFrame: 90 +/- 14 days following initiation of drug regimen
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Penny Asbell, • MD
role: PRINCIPAL_INVESTIGATOR
References: