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

Alcon

Status: Not yet enrolling

Conditions: Dry Eye Disease

Treatments: Other: Tears Naturale Free lubricating eye drops; Other: Tears Naturale II lubricating eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT07540884

LCC222-I001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Tears Naturale Free

Experimental group

Description:

One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)

Treatment:

Other: Tears Naturale Free lubricating eye drops

Tears Naturale II

Experimental group

Description:

One to two drops of artificial tears per eye as needed for 30 days (-2/+5 days)

Treatment:

Other: Tears Naturale II lubricating eye drops