Systane® Ultra Preservative Free Lubricant Eye Drops
- Conditions
- Dry Eye
- Interventions
- Other: Polyethylene glycol 400 and propylene glycol solution/drops
- Registration Number
- NCT05902364
- Lead Sponsor
- Alcon Research
- Brief Summary
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.
- 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 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Systane Ultra Preservative-Free Polyethylene glycol 400 and propylene glycol solution/drops 1-2 drops in each eye four times a day for 30 days
- Primary Outcome Measures
Name Time Method Mean overall IDEEL-Symptom Bother(SB) score - Group 1 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.
Resultant overall CLDEQ-8 score - Group 2 Visit 3 (Day 30) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Waterloo School of Optometry
🇨🇦Waterloo, Ontario, Canada
Integra Eye Care
🇨🇦Burnaby, British Columbia, Canada