Back to resultsSystane® Complete Preservative Free Lubricant Eye Drops
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Propylene glycol solution/drops
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 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
- Aggarwal and Associates LimitedRecruiting
- Eyes on Sheppard ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systane Complete Preservative-Free
Arm Description
1-2 drops in each eye four times a day for 30 days
Outcomes
Primary Outcome Measures
Mean overall IDEEL-Symptom Bother(SB) score
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05932225
Brief Title
Systane® Complete Preservative Free Lubricant Eye Drops
Official Title
Systane® Complete Preservative Free Lubricant Eye Drops
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (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 Complete Preservative Free (PF) Lubricant Eye Drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by DED groups.
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 a patient questionnaire on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB].
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systane Complete Preservative-Free
Arm Type
Experimental
Arm Description
1-2 drops in each eye four times a day for 30 days
Intervention Type
Other
Intervention Name(s)
Propylene glycol solution/drops
Other Intervention Name(s)
Systane Complete Preservative-Free
Intervention Description
commercially available eye drops
Primary Outcome Measure Information:
Title
Mean overall IDEEL-Symptom Bother(SB) score
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject must be able to understand and sign an informed consent form
Subject with mild to moderate dry eye
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
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Eyes on Sheppard Clinic
City
North York
State/Province
Ontario
ZIP/Postal Code
M2N 3A1
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Systane® Complete Preservative Free Lubricant Eye Drops
We'll reach out to this number within 24 hrs