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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Hydration Preservative Free (PF) | Experimental | 1-2 drops in each eye four times a day for 30 days |
|
| Systane Hydration Preserved | Experimental | 1-2 drops in each eye four times a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF) | Other | commercially available eye drops |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integra Eye Care | Burnaby | British Columbia | V5E 1G3 | Canada | ||
| Aggarwal and Associates Limited |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000595213 | polyethylene glycol 400 |
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|
| Polyethylene glycol 400 and propylene glycol solution/drops - Preserved | Other | commercially available eye drops |
|
|
| Brampton |
| Ontario |
| L6T 0G1 |
| Canada |
| University of Waterloo School of Optometry | Waterloo | Ontario | N2L 3G1 | Canada |