Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops

Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease

The purpose of this post-market clinical follow-up (PMCF) study is to describe the effectiveness and safety of Tears Naturale® Free and Tears Naturale® II lubricant eye drops in subjects experiencing dry eye (DE) symptoms.

Each subject's participation will last approximately 30 days and include three scheduled visits: a screening/baseline clinic visit on Day 1 (Visit 1), a telephone follow-up visit on Day 15 (-2/+5 days) (Visit 2), and an in-office visit on Day 30 (-2/+5 days) (Visit 3).

This study will be conducted in Canada.

Key Inclusion Criteria:

• Able to read, understand, and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form in English or French.
• Able to attend all study visits as required as per protocol.
• Mild to moderate dry eye disease.
• Willing to discontinue use of all habitual artificial tear supplements and use only the study device for the entire study duration.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any known allergic reactions to the study products or its ingredients.
• Ocular injury to either eye in the past 3 months prior to screening.
• Ocular surgery within the previous 6 months or ocular surgery planned during the study.
• Use of any systemic medication known to cause dry eye for less than 1 month before the Screening/Baseline visit.
• Other protocol-defined exclusion criteria may apply.