NIH Registers PMCF Study for Tears Naturale Eye Drops

NIH registered a new post-market clinical follow-up study on ClinicalTrials.gov for Tears Naturale Free and Tears Naturale II lubricant eye drops. The study aims to describe the effectiveness and safety of these over-the-counter lubricating eye drops in subjects experiencing dry eye disease symptoms.

Affected parties include pharmaceutical manufacturers marketing lubricant eye drops, clinical investigators conducting ophthalmic research, and healthcare providers prescribing dry eye treatments. As a clinical trial registration record, this document does not impose compliance obligations but provides transparency into ongoing post-market safety surveillance for these products.