Systane® Ultra Preservative Free Lubricant Eye Drops

Study Overview
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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.

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).

Official Title
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Systane® Ultra Preservative Free Lubricant Eye Drops

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Polyethylene glycol 400 and propylene glycol solution/drops


Participation Criteria
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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 CL-related dry eye symptoms Other protocol-defined inclusion criteria may apply 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. Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane Ultra Preservative-Free<br>1-2 drops in each eye four times a day for 30 days | Other: Polyethylene glycol 400 and propylene glycol solution/drops<br>* commercially available eye drops<br>* Other names: Systane Ultra Preservative-Free;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean overall IDEEL-Symptom Bother(SB) score - Group 1 | The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint. | Visit 3 (Day 30) | 
| Resultant overall CLDEQ-8 score - Group 2 | The CLDEQ-8 is an eight-item questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. Each question is answered using a 0-4, 0-5, or 1-6 Likert scale for a resultant overall score of 1-37. No statistical hypothesis is pre-specified for this endpoint. | Visit 3 (Day 30) |