Systane® Complete Preservative Free Lubricant Eye Drops
Status
Conditions
Treatments
Details and patient eligibility
About
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 Dry Eye Disease (DED) group.
Full description
Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, 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 the Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Subject must be able to understand and sign an informed consent form
- Subject with mild to moderate dry eye
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
71 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Alcon Call Center
Data sourced from clinicaltrials.gov
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