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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tears Naturale Free lubricating eye drops
Other interventionCommercially available, preservative free, artificial tear product containing dextran 70 and hypromellose. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.
Tears Naturale II lubricating eye drops
Other interventionCommercially available, artificial tear product containing dextran 70 and hypromellose with a gentle preservative for multi-dose use. Artificial tear products are designed to relieve dryness and irritation by supplementing and stabilizing the tear film.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Tears Naturale FreeExperimental treatment 1 intervention
Group B: Tears Naturale IIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score is calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother.
Time frame
Screening/Baseline Visit (Day 1), Day 30Sponsors and contacts
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Source ClinicalTrials.gov