Overview
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.
Description
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.
Eligibility
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.
