Back to resultsSystane® Hydration PF and Systane® Hydration Preserved
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)
Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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
Sites / Locations
- Alcon Call Center for Trial LocationsRecruiting
- Aggarwal and Associates LimitedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Systane Hydration Preservative Free (PF)
Systane Hydration Preserved
Arm Description
1-2 drops in each eye four times a day for 30 days
1-2 drops in each eye four times a day for 30 days
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05932238
Brief Title
Systane® Hydration PF and Systane® Hydration Preserved
Official Title
Systane® Hydration PF and Systane® Hydration Preserved
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systane Hydration Preservative Free (PF)
Arm Type
Experimental
Arm Description
1-2 drops in each eye four times a day for 30 days
Arm Title
Systane Hydration Preserved
Arm Type
Experimental
Arm Description
1-2 drops in each eye four times a day for 30 days
Intervention Type
Other
Intervention Name(s)
Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)
Other Intervention Name(s)
Systane Hydration Preservative Free (PF)
Intervention Description
commercially available eye drops
Intervention Type
Other
Intervention Name(s)
Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
Other Intervention Name(s)
Systane Hydration Preserved
Intervention Description
commercially available eye drops
Primary Outcome Measure Information:
Title
Mean overall IDEEL-Symptom Bother(SB) score - Group 1
Description
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.
Time Frame
Visit 3 (Day 30)
Title
Resultant overall CLDEQ-8 score - Group 2 and Group 3
Description
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.
Time Frame
Visit 3 (Day 30)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alcon Call Center
Phone
1-888-451-3937
Email
alcon.medinfo@alcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alcon Call Center
Email
alcon.medinfo@alcon.com
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Systane® Hydration PF and Systane® Hydration Preserved
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