Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

A Multi-Center, Single Arm, Post-Market Clinical Follow-up Study to Evaluate the Safety and Efficacy of NovaTears® + Omega-3 (0.2%) Eye Drops on Signs and Symptoms of Dry Eye

This PMCF study is carried out following successful CE marking of NovaTears® + Omega-3 and is intended to generate systematic clinical data on the safety and performance of the device when used in accordance with the intended purpose.

Inclusion Criteria:

• Signed ICF (Informed Consent Form) and data protection form
• Patient-reported history of DED in both eyes
• Have an Ocular Surface Disease Index (OSD) score ≥ 25 at Visit 1
• Have Meibomian Gland Dysfunction (MGD) at Visit 1.
• Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

• Women who are pregnant, nursing or planning a pregnancy
• Ocular surface pathology, clinically significant slit-lamp findings, abnormal lid anatomy, active ocular allergies
• Wear of contact lenses
• Known allergy or sensitivity to the medical device or its components
• Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 60 days before Visit 1.
• Clinical site employees or immediate family members of the same