NCT02014922.

Trial name or title	a study to determine the relief of dry eye symptoms with the use of TheraTears® products (DUNLIN)
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): 33 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: Canada Age (mean ± SD, range): 18 to 65 years (planned) Gender: both (planned) Inclusion criteria: between 18 and 65 years of age and has full legal capacity to volunteer; read and signed an information consent letter; willing and able to follow instructions and maintain the appointment schedule; symptoms of dry eye for at least 3 months; OSDI score of ≥ 23; currently on a non‐omega 3 dry eye treatment regimen that, at the minimum consists of instilling artificial tears at least once a day for the past 3 months; an average non‐invasive tear breakup time ≤ 5.00 seconds in at least one eye. Exclusion criteria: participating in any concurrent clinical or research study; has any known active* ocular disease and/or infection and/or allergies;* For the purposes of study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are typical findings and are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active; a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; known sensitivity to the diagnostic pharmaceuticals to be used in the study; pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally; aphakic; undergone refractive error surgery; take part in another (pharmaceutical) research study within the last 30 days; worn contact lenses within the past 5 years; currently using or have used omega 3 supplements in the past 3 months. Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: TheraTears® lubricant eye drop, TheraTears® preservative‐free single‐use containers, TheraTears® Nutrition, and TheraTears® TheraLid® eyelid cleanser Intervention #2 (control): no treatment Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): OSDI; visual analogue scores; tear osmolarity; TBUT; corneal staining Secondary outcome(s): lid wiper epitheliopathy; meibomian gland expressibility; meibum quality; tear film lipid layer thickness; tear meniscus height, Schirmer test Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, 1 month and 3 months Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	December 2013
Contact information	Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science, Waterloo, Ontario, Canada, N2L3G1
Notes	Recruitment status: completed Actual completion date: November 2014 Last update posted: March 11, 2015