Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlcon Research
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tears Naturale Free lubricating eye drops
- Tears Naturale II lubricating eye drops
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov