A Double-Masked, Randomized, Parallel Group, Non-Inferiority 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
Subject must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and must be able to read, understand, and provide written voluntary informed consent on the Ethics Committee (EC) approved ICF.
Subject who is able and willing to comply with all treatment and follow-up/study procedures.
Subject who have a history of using tear substitutes for at least 1 month prior to Visit 0 (Screening), and who will use preservative-free tear substitute (Artelac® Splash MDO®) at least 3 times a day for at least 10 days (± 3 days) immediately prior to randomization. All previously used tear substitutes will be discontinued at Visit 0 (Screening).
Subject with dry eye disease (DED) secondary to Sjögren's disease with clear functional disorders or subjects with epidermolysis bullosa, or ocular pemphigoid, absence or damage to the lacrimal gland, facial paralysis or lagophthalmos requiring use of tear substitutes.
Subject who has received ocular surgery, including laser surgery, intraocular injections in either eye within 90 days prior to study start.
Subject with acute ocular trauma, acute (non-dry eye) ocular inflammation, or acute ocular infection in either eye within 45 days prior to study start.
Subject with known hypersensitivity or contraindications to any of the ingredients in the study or comparator products or ART, (especially, hyaluronic acid, glycerol, Myritol and carbomer)
Subject with initiation of, or changes to, concomitant treatments that could affect dry eye within 30 days prior to Visit 0 (Screening) or with planned initiation, changes of such treatments during the study unless the investigator considers it clinically irrelevant.
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Lead sponsor