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Recruiting
NCT07540884
Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
Conditions: Dry Eye Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Alcon Research
Location: Integra Eyecare Centre Burnaby British Columbia
Summary
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 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.
Source: ClinicalTrials.gov (NCT07540884). StuddyBuddy aggregates publicly available trial information.