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

RecruitingNA

Sponsor: Alcon Research

Conditions: Dry Eye Disease

Interventions: Tears Naturale Free lubricating eye drops, Tears Naturale II lubricating eye drops

Countries: Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (6)

Burnaby, British Columbia, Canada
Kelowna, British Columbia, Canada
North York, Ontario, Canada
Toronto, Ontario, Canada
Boisbriand, Quebec, Canada
Chicoutimi, Quebec, Canada