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NCT05932225 Clinical Trial

Systane® Complete Preservative Free Lubricant Eye Drops

Dry Eye Clinical Trial

Official title:
Systane® Complete Preservative Free Lubricant Eye Drops

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05932225
Other study ID # DEC262-I001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2023
Est. completion date February 20, 2024

Study information
Verified date March 2024
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date February 20, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Propylene glycol solution/drops
commercially available eye drops

Locations
Country Name City State
Canada Aggarwal and Associates Limited Brampton Ontario
Canada Integra Eye Care Burnaby British Columbia
Canada Eyes on Sheppard Clinic North York Ontario
Canada University of Waterloo Centre for Contact Lens Research Waterloo Ontario

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Visit 3 (Day 30)
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