NCT00344721.

Trial name or title	A placebo controlled double masked clinical assessment study of essential fatty acid supplement and its effect on patients with apparent aqueous deficient dry eye syndrome
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 42 participants Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported 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): not reported Gender: not reported Inclusion criteria: 1. Patient over 18 years of age 2. Patient willing and able to comply with the protocol; no planned changes in diet, topical or systemic drugs during course of study 3. Ocular symptoms consistent with dry eye of insidious onset and greater than 3 months' duration 4. Ocular surface vital staining consistent with aqueous deficient dry eyes with less than +1 conjunctival injection and no more than minimal lid inflammation Exclusion criteria: 1. Patients who use topical eye drops other than artificial tears 2. Patients with punctal occlusion or punctal plugs 3. Patients with active ocular infection or inflammatory disease 4. History of herpetic keratitis 5. History of retinal detachment 6. Concurrent contact lens use during the trial period 7. Ocular surgery within the past 6 months 8. Patients with glaucoma, anterior membrane dystrophy, active trichiasis, or any eyelid globe malposition abnormality (eg, entropion, ectropion) 9. Patients with epiphora (excessive tearing) 10. Patients taking medications known to affect aqueous tear production or meibomian secretions 11. Patient must not have participated in (or be currently participating in) any investigational therapeutic drug or device trial within the previous 30 days before the start date for this trial 12. Patients suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: omega‐3 fatty acid supplement, containing a daily dose of EPA (eicosapentaenoic acid) 450 mg, DHA (docosahexaenoic acid) 300 mg, and flaxseed oil (organic) 1000 mg Intervention #2 (control): placebo supplements, containing wheat germ oil but not essential fatty acids Length of follow‐up: not reported Notes: patient's topical therapy will be standardized after identification exam, so that all patients will use TheraTears™ 4 times daily
Outcomes	Primary outcome(s): meibomian gland secretion lipid biochemistry changes (before and after treatment) Secondary outcome(s): tear evaporation rate and tear fluorophometry (both measured before and after treatment) Adverse events reported? (Y/N): N 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	September 2004
Contact information	James McCulley University of Texas, Southwestern Medical Center at Dallas, USA
Notes	Recruitment status: completed Actual completion date: October 2008 Last update posted: May 2018