Systane® Ultra 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 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.
Full 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 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).
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
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
70 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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