Evaluating Artelac Complete MDO Versus VISMED MULTI Eye Drops for Moderate to Severe Dry Eye Disease in Adults

What this Trial Is About

Researchers are studying the management of moderate to severe dry eye disease by comparing two types of eye drops Artelac Complete MDO and VISMED MULTI. The study aims to evaluate the performance and safety of these treatments. It is a double-masked, randomized, parallel group, non-inferiority study sponsored by Dr. Gerhard Mann chem.-pharm. Fabrik GmbH. Participants will self-administer either Artelac Complete MDO eye drops or VISMED MULTI eye drops. The study involves a treatment period leading to a key assessment at Day 90 Visit 3. Before randomization, participants will use a preservative-free tear substitute at least three times daily for around 10 days. The study compares the two treatments by measuring eye health and dry eye symptoms over time. During the study, participants will have their dry eye symptoms evaluated using the Ocular Surface Disease Index OSDI score at baseline and Day 90. Other assessments include tear film break-up time and ocular surface staining at screening and randomization visits. The primary outcome is the change in total OSDI score after 90 days. Participants must comply with treatment and follow-up visits, which will monitor safety and treatment effects throughout the study duration.

A Study to Evaluate the Performance and Safety of Artelac® Complete MDO® Versus VISMED® MULTI Eye Drops in the Management of Moderate to Severe Dry Eye Disease