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. 2019 Dec 18;2019(12):CD011016. doi: 10.1002/14651858.CD011016.pub2

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