Systane® Hydration PF and Systane® Hydration Preserved
1 other identifier
interventional
137
1 country
3
Brief Summary
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedStudy Start
First participant enrolled
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2024
CompletedSeptember 19, 2024
September 1, 2024
11 months
June 27, 2023
September 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Mean overall IDEEL-Symptom Bother(SB) score - Group 1
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.
Visit 3 (Day 30)
Resultant overall CLDEQ-8 score - Group 2 and Group 3
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.
Visit 3 (Day 30)
Study Arms (2)
Systane Hydration Preservative Free (PF)
EXPERIMENTAL1-2 drops in each eye four times a day for 30 days
Systane Hydration Preserved
EXPERIMENTAL1-2 drops in each eye four times a day for 30 days
Interventions
commercially available eye drops
commercially available eye drops
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (3)
Integra Eye Care
Burnaby, British Columbia, V5E 1G3, Canada
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Lead, Vision Care
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
October 6, 2023
Primary Completion
September 5, 2024
Study Completion
September 5, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09