Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
No applicable phase (e.g. observational)
Conditions:
Dry Eye Disease
Sponsor: Alcon Research
trial.available_in:
БГ
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.
Who can participate
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.