Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial.

ABSTRACT:

Purpose

To assess the safety and efficacy of multi-ingredient sacha inchi microemulsion (SIME) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye.

Methods

This randomized, quadruple-masked, active-controlled parallel study in 64 adult patients comprised three parts. Part 1 (n = 3): one eye was treated with SIME for one day. Part 2 (n = 9): randomized eyes were treated with SIME and 0.2% hyaluronic acid (HA) control eye drops 3 times a day for 10 days. Part 3 (n = 26 + 26): randomized treatment was applied on both eyes 3 times a day for 30 days. OSDI change was tested for superiority of SIME over HA. Ocular assessments were performed at baseline and after the last dose.

SUBMITTER: Laihia J 

PROVIDER: S-EPMC7216857 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature