Hom 2017.
Methods |
Study design: randomized, parallel‐group, controlled trial Number randomized (total and per group): 242 participants |
Participants |
Country: not reported Age (mean ± SD, range): not reported Gender: not reported Inclusion criteria: dry eye (details not reported) Exclusion criteria: not reported |
Interventions |
Intervention #1: eye drop containing flaxseed oil and trehalose Intervention #2 (control): marketed lipid‐containing eye drop (Refresh Optive® Advanced, ROA) Length of follow‐up: 90 days Notes: followed 1 ‐week run‐in with a standard aqueous tear (Refresh Plus®) |
Outcomes |
Primary outcome(s): change from baseline in Ocular Surface Disease Index (OSDI) score Secondary outcome(s): tear break‐up time (TBUT); ocular surface staining, Schirmer test; dry eye symptoms survey Adverse events reported? (Y/N): Y, ocular safety assessment Measurement time points (specify intervals at which outcomes were assessed): 90 days (other time points not reported in the abstract) Other issues with outcome assessment (eg, quality control for outcomes, if any): |
Notes |
Recruitment status: completed Actual completion date: not reported, but completed Last update posted: not reported |