Systane® Hydration PF and Systane® Hydration Preserved

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 Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.

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® Hydration PF and Systane® Hydration Preserved

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)
* Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved


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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 and Group 3 | 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) |