Laihia 2019.

Methods	Study design: randomized, parallel‐group, controlled trial Number randomized (total and per group): 52 participants total (Part 3); 26 each
Participants	Country: Finland Age (mean ± SD, range):53.3 ± 12.6, range 26‐78 years Gender: 16 men and 36 women Inclusion criteria: 18–80 years of age;either (1) OSDI ≥20 and TBUT <10 seconds, or (2) OSDI ≥20 and positive ocular (corneal and conjunctival) staining pattern by Oxfordgrading; body weight ≥45 kg; under stable topical and/or systemic therapy for ≥4 weeks before study procedures and ability to abstain from other therapies during study; and ability and willingness to self‐administer eye drops Exclusion criteria: medical history of ocular surgery, trauma or refractive laser vision correction procedure <3 months earlier; corneal/conjunctival infection; Sjogren’s syndrome; contact lens use during study and <1 week earlier; ocular allergic symptoms; known allergy to eye drop constituents; current or planned pregnancy or nursing during study
Interventions	Intervention #1: sacha inchi microemulsion (SIME; Finnsusp, Lieto, Finland), an eye drop formulation with 0.1% sacha inchi (Plukenetia volubilis) seed oil Intervention #2 (control): 0.2% medium‐molecular‐weight hyaluronic acid in isotonic phosphate saline buffer (Finnsusp) Length of follow‐up: 30 days Notes: none
Outcomes	Primary outcome(s): tear osmolarity; TBUT Secondary outcome(s): blink rate; corneal and conjunctival staining; OSDI Adverse events reported? (Y/N): Y Measurement time points (specify intervals at which outcomes were assessed): baseline, 30 days Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Notes	Recruitment status: completed Actual completion date: not reported, but completed Last update posted: published