Systane® Ultra Preservative Free Lubricant Eye Drops
- Conditions
- Dry Eye
- 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
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- Subject must be able to understand and sign an informed consent form.
- Subject with mild to moderate dry eye.
- Subject with contact lens-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
- Primary Outcome Measures
Name Time Method Mean Overall IDEEL SB Score - Group 1 Baseline (Day 1), Day 30 The Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) module is a 20-item, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each item, the subject selected a single response for both eyes, where 0 = "None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4 = "All of the time" (Q1) or "Very Much" (Q2-20). The overall score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint. This endpoint was pre-specified for Group 1
Mean Overall CLDEQ-8 Score - Group 2 Baseline (Day 1), Day 30 The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is an 8-item, patient-reported outcome questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. For each item, the subject selected a single response for both eyes using a 0-4, 0-5, or 1-6 Likert scale. The overall score was calculated as the sum of the numerical responses for each of the 8 items and ranged from 1 (minimum) to 37 (maximum). A lower CLDEQ-8 score indicates less frequent or less intense symptoms. Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). No statistical hypothesis is pre-specified for this endpoint. This endpoint was prespecified for Group 2 only.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Auckland
🇳🇿Grafton, Auckland, New Zealand
Rose Optometry
🇳🇿Frankton, Otago, New Zealand
Integra Eye Care
🇨🇦Burnaby, British Columbia, Canada
University of Waterloo School of Optometry
🇨🇦Waterloo, Ontario, Canada
University of Auckland🇳🇿Grafton, Auckland, New Zealand