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NCT Number: NCT07540884

Evaluation of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integra Eyecare Centre, Burnaby, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

Tears Naturale Free lubricating eye drops

Other

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 drops

Other

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alcon Call Center

CONTACT

[email protected]

1-888-451-3937

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Evaluation of the Safety and Effectiveness of Tears Naturale® Free and Tears Naturale® II Lubricant Eye Drops in Subjects With Dry Eye Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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