Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tears Naturale Free lubricating eye drops, Tears Naturale II lubricating eye drops.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
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.
Interventions
- Other Tears Naturale Free lubricating eye drops
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. - Other Tears Naturale II lubricating eye drops
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.
Primary outcome measures
- Mean Impact of Dry Eye on Everyday Life - Symptom Bother Module (IDEEL - SB) Score [Time frame: Screening/Baseline Visit (Day 1), Day 30]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 6 centers
- Integra Eyecare Centre — Burnaby
- The Medical Arts Health Research Group — Kelowna
- Eyes on Sheppard — North York
- Dr. Shalu Pal & Associates — Toronto
- Institut de L'Oeil des Laurentides — Boisbriand
- Hopital de Chicoutimi and LASIK MD — Chicoutimi
Identifiers
NCT: NCT07540884 · LCC222-I001