Systane® Ultra Preservative Free Lubricant Eye Drops

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-28

Study Completion Date

2024-08-14

Brief Summary

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The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.

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Detailed Description

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Subjects will participate in the study for approximately 30 days, with a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\] or Contact Lens Dry Eye Questionnaire \[CLDEQ-8\] and Comfortable Wear Time questions).

Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Dry Eye Symptoms

1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days

Group Type EXPERIMENTAL

Systane Ultra PF lubricant eye drops

Intervention Type OTHER

Commercially available preservative free eye drops

Group 2 - CL-Related Dryness Discomfort

1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days

Group Type EXPERIMENTAL

Systane Ultra PF lubricant eye drops

Intervention Type OTHER

Commercially available preservative free eye drops

Interventions

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Systane Ultra PF lubricant eye drops

Commercially available preservative free eye drops

Intervention Type OTHER

Other Intervention Names

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Systane Ultra Preservative-Free

Eligibility Criteria

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Inclusion Criteria

* Subject must be able to understand and sign an informed consent form.
* Subject with mild to moderate dry eye.
* Subject with contact lens-related dry eye symptoms.

Exclusion Criteria

* Has suffered any ocular injury to either eye in the past 3 months prior to screening.
* Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes