NCT01102257.

Trial name or title	Clinical trial of essential fatty acids for dry eye disease: feasibility study
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): not reported Number randomized (total and per group): 18 participants in total; 9 in each treatment group Unit of randomization (individual or eye): not reported Exclusions after randomization: 2 participants (due to adverse events), both in the omega‐3 intervention group Losses to follow‐up: none Number analyzed (total and per group): 16 participants in total; 7 in the omega‐3 intervention group; 9 in the placebo group Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: United States Age (mean ± SD, range): 56 ± 14 years in total; 55 ± 14 years in the omega‐3 intervention group; 57 ± 15 years in the placebo group Gender: 3 men and 15 women in total; 1 man and 8 women in the omega‐3 intervention group; 2 men and 7 women in the placebo group Inclusion criteria: 1. Signed and dated informed consent form approved by the IRB 2. ≥ 18 years of age 3. Demonstrated at least 2 of the 4 following signs in the same eye at 2 consecutive visits (visit 1: 7 to 21 days before randomization, and visit 2: day of randomization): (a) conjunctival staining present ≥ 1; (b) corneal fluorescein staining present ≥ 1; (c) tear film break‐up time (TBUT) ≤ 7 seconds; (d) Schirmer test ≤ 7 mm/5 min 4. Demonstrated 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 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. Must be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff 9. Must be able to swallow large, soft gel caps Exclusion criteria: 1. Patients who are allergic to ingredients of active or placebo pills (fish, olive oil) 2. Current diagnosis of ocular infection (eg, bacterial, viral, fungal) 3. History of ocular herpetic keratitis 4. Eye surgery (including cataract surgery) within 6 months before 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 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 punctal plugs 13. Use of punctal 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/d 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 Equivalence of baseline characteristics? (Y/N): Y
Interventions	Intervention #1 (omega‐3 treatment group): total daily dose of eicosapentaenoic acid 2000 mg and docosahexaenoic acid 1000 mg (from 5 capsules) Intervention #2 (control group): placebo (olive oil), 5 capsules daily containing 3000 mg of olive oil Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): change in OSDI and red blood cell membrane fatty acid content Secondary outcome(s): change in each of Brief Ocular Discomfort Inventory (BODI); Impact of Dry Eye on Everyday Life (IDEEL); Quality of Life Associated With Chronic Pain; ocular surface; Schirmer test; HLA‐DR; MUC 5A; cytokines Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes if any): none
Starting date	January 2010
Contact information	Penny Asbell, MD
Notes	Recruitment status: completed Last post updated: August 2012