Systane® Complete Preservative Free Lubricant Eye Drops
Study Details
Study Description
Brief Summary
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) Lubricant Eye Drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by DED groups.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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 a patient questionnaire on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB].
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Systane Complete Preservative-Free 1-2 drops in each eye four times a day for 30 days |
Other: Propylene glycol solution/drops
commercially available eye drops
Other Names:
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Outcome Measures
Primary Outcome Measures
- Mean overall IDEEL-Symptom Bother(SB) score [Visit 3 (Day 30)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject must be able to understand and sign an informed consent form
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Subject with mild to moderate dry eye
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Other protocol-defined inclusion criteria may apply
Exclusion Criteria:
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Has suffered any ocular injury to either eye in the past 3 months prior to screening.
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Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
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Other protocol-defined exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEC262-I001