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Not yet recruiting Not applicable NCT07540884

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.
Interventions
Tears Naturale Free lubricating eye drops
OTHER
Tears Naturale II lubricating eye drops
OTHER
Locations 5
Canada (5)
Institut de L'Oeil des Laurentides
Boisbriand , Quebec
Integra Eyecare Centre
Burnaby , British Columbia
The Medical Arts Health Research Group
Kelowna , British Columbia
Eyes on Sheppard
North York , Ontario
Dr. Shalu Pal & Associates
Toronto , Ontario
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.08.2026
Registry ID
NCT07540884
Source
clinicaltrials.gov
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