Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease
1 other identifier
interventional
120
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 15, 2026
CompletedFirst Posted
Study publicly available on registry
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
April 21, 2026
April 1, 2026
4 months
April 15, 2026
April 15, 2026
Conditions
Keywords
Outcome Measures
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.
Screening/Baseline Visit (Day 1), Day 30
Study Arms (2)
Tears Naturale Free
EXPERIMENTALOne to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
Tears Naturale II
EXPERIMENTALOne to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)
Interventions
Commercially 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.
Commercially 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (5)
Integra Eyecare Centre
Burnaby, British Columbia, V5E 1G3, Canada
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7, Canada
Eyes on Sheppard
North York, Ontario, M2N 3A1, Canada
Dr. Shalu Pal & Associates
Toronto, Ontario, M5R 2A5, Canada
Institut de L'Oeil des Laurentides
Boisbriand, Quebec, J7H 0E8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Dry Eye
Alcon Research, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2026
First Posted
April 21, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share