Dry Eye DiseaseNCT07540884
Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
A study testing Tears Naturale Free lubricating eye drops and Tears Naturale II lubricating eye drops in people with Dry Eye Disease, run by Alcon Research at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Tears Naturale Free lubricating eye drops and Tears Naturale II lubricating eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 6 sitesCanada
- Study dates
- 4 Jun 2026to 14 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Institut de L'Oeil des Laurentides
Boisbriand, Quebec, J7H 0E8
Integra Eyecare Centre
Burnaby, British Columbia, V5E 1G3
Hopital de Chicoutimi and LASIK MD
Chicoutimi, Quebec, G7H 7W8
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 4N7
Eyes on Sheppard
North York, Ontario, M2N 3A1
Dr. Shalu Pal & Associates
Toronto, Ontario, M5R 2A5
About this study
Official title: Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease
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.
Read the detailed 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.
- Conditions
- Dry Eye Disease
- Being tested
- Tears Naturale Free lubricating eye drops, Tears Naturale II lubricating eye drops
- Keywords
- lubricating eye drops, dry eyes, artificial tears
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tears Naturale Free lubricating eye dropsOther
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.
Tears Naturale II lubricating eye dropsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tears Naturale Free | Experimental | One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) Receives: Other: Tears Naturale Free lubricating eye drops |
| Tears Naturale II | Experimental | One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) Receives: Other: Tears Naturale II lubricating eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening/Baseline Visit (Day 1), Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start4 Jun 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Dry Eye, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540884
- Sponsor's protocol ID
- LCC222-I001
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07540884
- Acronym / sponsor ID
- LCC222-I001
- Conditions
- Dry Eye Disease
- Keywords
- lubricating eye drops, dry eyes, artificial tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tears Naturale Free | Experimental | Other: Tears Naturale Free lubricating eye dropsOne to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) |
| Tears Naturale II | Experimental | Other: Tears Naturale II lubricating eye dropsOne to two drops of artificial tears per eye as needed for 30 days (-2/+5 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tears Naturale Free lubricating eye dropsCommercially 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. | Other | Tears Naturale Free |
| Tears Naturale II lubricating eye dropsCommercially 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. | Other | Tears Naturale II |
Primary outcome
Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score
Time frame: Screening/Baseline Visit (Day 1), Day 30
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Dry Eye study director
Alcon Research, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tears Naturale Free lubricating eye drops and Tears Naturale II lubricating eye drops in people with Dry Eye Disease, run by Alcon Research at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score (time frame: Screening/Baseline Visit (Day 1), Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.